Trial Outcomes & Findings for Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer (NCT NCT01855828)
NCT ID: NCT01855828
Last Updated: 2020-03-31
Results Overview
To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
20 weeks
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=50 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|
|
Age, Continuous
|
51 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
36 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
|
Hormone receptor status
Estrogen Receptor + / Progesterone Receptor +
|
20 Participants
n=99 Participants
|
|
Hormone receptor status
Estrogen Receptor + / Progesterone Receptor -
|
4 Participants
n=99 Participants
|
|
Hormone receptor status
Estrogen Receptor - / Progesterone Receptor -
|
26 Participants
n=99 Participants
|
|
HER2 status
Fluorescence in situ hybridization (FISH) positive
|
27 Participants
n=99 Participants
|
|
HER2 status
Immunohistochemistry (IHC) 3+
|
23 Participants
n=99 Participants
|
|
Clinical Tumor Status
T1: Tumor is 2 cm or smaller
|
18 Participants
n=99 Participants
|
|
Clinical Tumor Status
T2: Tumor is larger than 2 cm, but no larger than
|
25 Participants
n=99 Participants
|
|
Clinical Tumor Status
T3: Tumor is larger than 5 cm
|
5 Participants
n=99 Participants
|
|
Clinical Tumor Status
T4: Tumor is any size, but has spread
|
2 Participants
n=99 Participants
|
|
Type of surgery
Mastectomy
|
35 Participants
n=99 Participants
|
|
Type of surgery
Breast conserving surgery
|
13 Participants
n=99 Participants
|
|
Type of surgery
No surgery (dropped out of study)
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: For ER-negative cancers, the maximum sample size was set to n = 25 and the regimen would be considered of interest if \> 20 patients achieve pCR. For ER-positive patients, the maximum sample size for the ER-positive cohort was set to 39 and the regimen would be considered of interest in this subgroup if \> 23 patients achieve pCR.
To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.
Outcome measures
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=48 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|---|---|
|
Proportion of Participants With a Pathologic Complete Response Rate
HR Positive
|
.26 proportion of participants
Interval 0.13 to 0.46
|
—
|
—
|
|
Proportion of Participants With a Pathologic Complete Response Rate
HR Negative
|
.80 proportion of participants
Interval 0.6 to 0.91
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post surgeryPopulation: All patients are assessed in each arm.
To assess the safety of the regimen, cardiac safety was measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF \>10%, and decrease of LVEF below normal level. This was assessed up to 1 year following surgery.
Outcome measures
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=50 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF
n=50 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level
n=50 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|---|---|
|
Cardiac Safety
|
0 Participants
|
14 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: All patients are assessed by HR-positive or HR-negative status.
To assess clinical response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the number of patients are presented with a clinical response.
Outcome measures
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=23 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF
n=25 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|---|---|
|
Count of Patients With Clinical Response
|
6 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 28 weeksPopulation: Total participants that were analyzed for this score (n=43).
To assess cancer burben, the Residual Cancer Burden (RCB) score was used. This score has a range of 0 - III, where III (3) is the worst level of burden.
Outcome measures
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=43 Participants
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-asympomatic Decrease in LVEF
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
Chemo Plus Pertuzumab,Trastuzumab-LVEF Below Normal Level
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|---|---|
|
Residual Cancer Burden Score
RCB = 0
|
28 Participants
|
—
|
—
|
|
Residual Cancer Burden Score
RCB = I (1)
|
5 Participants
|
—
|
—
|
|
Residual Cancer Burden Score
RCB = II (2)
|
4 Participants
|
—
|
—
|
|
Residual Cancer Burden Score
RCB = III (3)
|
4 Participants
|
—
|
—
|
Adverse Events
Chemo Plus Pertuzumab,Trastuzumab
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=50 participants at risk
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|
|
Infections and infestations
Catheter related infection
|
4.0%
2/50 • Number of events 2 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
1/50 • Number of events 1 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Fever
|
2.0%
1/50 • Number of events 1 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
1/50 • Number of events 1 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Flu like symptoms
|
2.0%
1/50 • Number of events 1 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/50 • Number of events 1 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
Other adverse events
| Measure |
Chemo Plus Pertuzumab,Trastuzumab
n=50 participants at risk
During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).
Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).
Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
72.0%
36/50 • Number of events 65 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Cardiac disorders
Palpitations
|
6.0%
3/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Eye disorders
Blurred vision
|
10.0%
5/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Eye disorders
Watering eyes
|
24.0%
12/50 • Number of events 13 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
10/50 • Number of events 12 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Constipation
|
28.0%
14/50 • Number of events 15 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
45/50 • Number of events 110 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
5/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Dyspepsia
|
14.0%
7/50 • Number of events 8 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
10/50 • Number of events 12 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Mucositis oral
|
38.0%
19/50 • Number of events 33 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Nausea
|
82.0%
41/50 • Number of events 67 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Stomach pain
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
13/50 • Number of events 18 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Edema limbs
|
16.0%
8/50 • Number of events 10 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Fatigue
|
86.0%
43/50 • Number of events 59 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Infusion related reaction
|
6.0%
3/50 • Number of events 4 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
General disorders
Pain
|
54.0%
27/50 • Number of events 49 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Immune system disorders
Allergic reaction
|
8.0%
4/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Infections and infestations
Nail infection
|
12.0%
6/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Infections and infestations
Skin infection
|
8.0%
4/50 • Number of events 4 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Infections and infestations
Upper respiratory infection
|
8.0%
4/50 • Number of events 4 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Infections and infestations
Urinary tract infection
|
12.0%
6/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
Alanine aminotransferase increased
|
54.0%
27/50 • Number of events 52 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
Alkaline phosphatase increased
|
12.0%
6/50 • Number of events 8 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
Aspartate aminotransferase increased
|
32.0%
16/50 • Number of events 20 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
Neutrophil count decreased
|
26.0%
13/50 • Number of events 21 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
Weight loss
|
8.0%
4/50 • Number of events 4 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Investigations
White blood cell decreased
|
42.0%
21/50 • Number of events 47 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
5/50 • Number of events 7 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.0%
8/50 • Number of events 13 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
10/50 • Number of events 19 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.0%
3/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
5/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
6/50 • Number of events 9 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
5/50 • Number of events 7 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
7/50 • Number of events 7 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.0%
7/50 • Number of events 7 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Dizziness
|
20.0%
10/50 • Number of events 12 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Dysgeusia
|
20.0%
10/50 • Number of events 11 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Headache
|
32.0%
16/50 • Number of events 20 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Paresthesia
|
8.0%
4/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.0%
7/50 • Number of events 8 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
25/50 • Number of events 34 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Psychiatric disorders
Anxiety
|
16.0%
8/50 • Number of events 10 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Psychiatric disorders
Insomnia
|
36.0%
18/50 • Number of events 21 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Renal and urinary disorders
Urinary frequency
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Renal and urinary disorders
Urinary tract pain
|
8.0%
4/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Reproductive system and breast disorders
Breast pain
|
10.0%
5/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
38.0%
19/50 • Number of events 22 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
9/50 • Number of events 10 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
10/50 • Number of events 10 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
70.0%
35/50 • Number of events 40 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.0%
8/50 • Number of events 10 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.0%
6/50 • Number of events 6 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
76.0%
38/50 • Number of events 50 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
8/50 • Number of events 8 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
36.0%
18/50 • Number of events 20 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
7/50 • Number of events 8 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
38.0%
19/50 • Number of events 24 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.0%
21/50 • Number of events 24 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.0%
4/50 • Number of events 5 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Vascular disorders
Flushing
|
6.0%
3/50 • Number of events 3 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Vascular disorders
Hot flashes
|
40.0%
20/50 • Number of events 22 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
|
|
Vascular disorders
Hypertension
|
14.0%
7/50 • Number of events 16 • Up to 28 weeks.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. This includes the following; AEs not previously observed in the subject that emerge during the protocol, specified AE reporting period. Complications that occur as a result of protocol-mandated interventions (e.g., invasive procedures such as cardiac catheterizations).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place