Trial Outcomes & Findings for Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer (NCT NCT04957212)
NCT ID: NCT04957212
Last Updated: 2024-07-26
Results Overview
bpCR defined as the absence of invasive neoplastic cells in the breast at microscopic examination of the primary tumor at surgery following primary systemic therapy (ypT0/is)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
18-20 weeks after first intervention
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
107
|
|
Overall Study
COMPLETED
|
107
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.56 years
STANDARD_DEVIATION 10.31 • n=99 Participants
|
44.35 years
STANDARD_DEVIATION 9.81 • n=107 Participants
|
45.95 years
STANDARD_DEVIATION 10.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
107 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
BMI
|
28.27 kg/m^2
STANDARD_DEVIATION 5.30 • n=99 Participants
|
27.27 kg/m^2
STANDARD_DEVIATION 4.38 • n=107 Participants
|
27.77 kg/m^2
STANDARD_DEVIATION 4.87 • n=206 Participants
|
|
BSA
|
1.79 m^2
STANDARD_DEVIATION 0.18 • n=99 Participants
|
1.79 m^2
STANDARD_DEVIATION 0.18 • n=107 Participants
|
1.79 m^2
STANDARD_DEVIATION 0.18 • n=206 Participants
|
|
IHC2+
FISH+
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
IHC2+
CISH+
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
IHC3+
|
98 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
ER/PR+
|
63 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
ER/PR-
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Type of breast cancer
Inflammatory
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Type of breast cancer
Locally advanced
|
49 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Type of breast cancer
Operable
|
52 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18-20 weeks after first interventionbpCR defined as the absence of invasive neoplastic cells in the breast at microscopic examination of the primary tumor at surgery following primary systemic therapy (ypT0/is)
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=105 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=102 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Breast Pathological Complete Response (bpCR)
|
71 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 18-20 weeks after first interventiontpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0)
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Total Pathological Complete Response (tpCR)
|
60 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 18-20 weeks after first interventionORR defined as the proportion of patients who achieved a complete or partial response
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Objective Response Rate (ORR)
Partial Response
|
30 Participants
|
29 Participants
|
|
Objective Response Rate (ORR)
Complete Response
|
64 Participants
|
61 Participants
|
|
Objective Response Rate (ORR)
Progressive Disease
|
2 Participants
|
3 Participants
|
|
Objective Response Rate (ORR)
Stable Disease
|
3 Participants
|
2 Participants
|
|
Objective Response Rate (ORR)
Unknown
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 18-20 weeks after first interventionRate of BCS for patients for whom mastectomy was planned before treatment (T2-3)
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=64 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=59 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Rate of Breast-conserving Surgery (BCS)
Lumpectomy
|
20 Participants
|
21 Participants
|
|
Rate of Breast-conserving Surgery (BCS)
Mastectomy
|
44 Participants
|
37 Participants
|
|
Rate of Breast-conserving Surgery (BCS)
Unknown
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Throughout the study duration (from first visit to week 18-20)Population: A total of 214 patients were analyzed for AEs.Reports were based on the Safety set. The safety set included all randomized patients who received at least one dose of the study drug.
Safety assessment, including the incidence of all reported AEs and abnormal laboratory results was done. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Safety Assessment Including Treatment Related Adverse Events
|
107 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: Throughout the study duration (from first visit to week 18-20)Laboratory data including CBC diff have been assessed. All abnormal values were recorded as adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 6 week (from first visit to week 18-20)LVEF decrease was measured by echocardiography. All cases with a decrease more than 10% from baseline which meet \<50%, will be recorded as adverse events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout the study duration (from first visit to week 18-20)In this study, LVSD was evaluated by measuring the decrease in LVEF (outcome measure 5) and assessing the clinical symptoms of the study participants based on physician opinion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 weeks (from first intervention to week 18)Population: A total of 214 patients were analyzed for immunogenicity assessment.
The enzyme-linked immunosorbent assay (ELISA) method was used for the assessment of anti-drug antibodies (ADAs).
Outcome measures
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 Participants
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Immunogenicity
|
0 Participants
|
0 Participants
|
Adverse Events
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
Serious events: 24 serious events
Other events: 107 other events
Deaths: 0 deaths
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
Serious events: 15 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 participants at risk
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 participants at risk
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Reproductive system and breast disorders
Dyspnoea
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Blood and lymphatic system disorders
anaemia
|
13.1%
14/107 • Number of events 19 • 18-20 weeks
|
9.3%
10/107 • Number of events 11 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
2/107 • Number of events 2 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
2/107 • Number of events 3 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
6/107 • Number of events 8 • 18-20 weeks
|
3.7%
4/107 • Number of events 4 • 18-20 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/107 • Number of events 3 • 18-20 weeks
|
0.93%
1/107 • Number of events 2 • 18-20 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/107 • Number of events 3 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.7%
4/107 • Number of events 4 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/107 • 18-20 weeks
|
4.7%
5/107 • Number of events 6 • 18-20 weeks
|
|
General disorders
Asthenia
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
General disorders
Chest pain
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
General disorders
Chills
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
General disorders
Decreased appetite
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
General disorders
Infusion related reaction
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
General disorders
Pain
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
General disorders
Pyrexia
|
1.9%
2/107 • Number of events 2 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Hepatobiliary disorders
Fatty liver
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Infections and infestations
Diarrhoea infectious
|
1.9%
2/107 • Number of events 2 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/107 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Infections and infestations
Perirectal abscess
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
|
Infections and infestations
Sepsis
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Nervous system disorders
Vertigo
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Psychiatric disorders
Agitation
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
|
Vascular disorders
Microangiopathy
|
0.93%
1/107 • Number of events 1 • 18-20 weeks
|
0.00%
0/107 • 18-20 weeks
|
Other adverse events
| Measure |
TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel)
n=107 participants at risk
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel)
n=107 participants at risk
Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.
Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks
Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
Docetaxel: 75 mg/m2 every 3-weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
96.3%
103/107 • Number of events 443 • 18-20 weeks
|
93.5%
100/107 • Number of events 477 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
63.6%
68/107 • Number of events 185 • 18-20 weeks
|
64.5%
69/107 • Number of events 201 • 18-20 weeks
|
|
Gastrointestinal disorders
Nausea
|
59.8%
64/107 • Number of events 114 • 18-20 weeks
|
66.4%
71/107 • Number of events 139 • 18-20 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
56.1%
60/107 • Number of events 107 • 18-20 weeks
|
62.6%
67/107 • Number of events 122 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
52.3%
56/107 • Number of events 127 • 18-20 weeks
|
47.7%
51/107 • Number of events 100 • 18-20 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
45.8%
49/107 • Number of events 95 • 18-20 weeks
|
43.9%
47/107 • Number of events 101 • 18-20 weeks
|
|
Gastrointestinal disorders
Vomiting
|
43.0%
46/107 • Number of events 82 • 18-20 weeks
|
49.5%
53/107 • Number of events 82 • 18-20 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
40.2%
43/107 • Number of events 66 • 18-20 weeks
|
34.6%
37/107 • Number of events 51 • 18-20 weeks
|
|
General disorders
Pain
|
35.5%
38/107 • Number of events 49 • 18-20 weeks
|
30.8%
33/107 • Number of events 42 • 18-20 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
34.6%
37/107 • Number of events 51 • 18-20 weeks
|
29.0%
31/107 • Number of events 52 • 18-20 weeks
|
|
Gastrointestinal disorders
Aphthous ulcer
|
11.2%
12/107 • Number of events 12 • 18-20 weeks
|
6.5%
7/107 • Number of events 7 • 18-20 weeks
|
|
Gastrointestinal disorders
Constipation
|
15.0%
16/107 • Number of events 30 • 18-20 weeks
|
18.7%
20/107 • Number of events 24 • 18-20 weeks
|
|
Gastrointestinal disorders
Dysgeusia
|
8.4%
9/107 • Number of events 11 • 18-20 weeks
|
7.5%
8/107 • Number of events 9 • 18-20 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
16.8%
18/107 • Number of events 18 • 18-20 weeks
|
9.3%
10/107 • Number of events 11 • 18-20 weeks
|
|
General disorders
Asthenia
|
32.7%
35/107 • Number of events 45 • 18-20 weeks
|
24.3%
26/107 • Number of events 42 • 18-20 weeks
|
|
General disorders
Chest pain
|
6.5%
7/107 • Number of events 7 • 18-20 weeks
|
6.5%
7/107 • Number of events 8 • 18-20 weeks
|
|
General disorders
Chills
|
12.1%
13/107 • Number of events 13 • 18-20 weeks
|
6.5%
7/107 • Number of events 8 • 18-20 weeks
|
|
General disorders
Decreased appetite
|
28.0%
30/107 • Number of events 40 • 18-20 weeks
|
29.0%
31/107 • Number of events 38 • 18-20 weeks
|
|
General disorders
Fatigue
|
20.6%
22/107 • Number of events 28 • 18-20 weeks
|
12.1%
13/107 • Number of events 16 • 18-20 weeks
|
|
General disorders
Flushing
|
10.3%
11/107 • Number of events 14 • 18-20 weeks
|
5.6%
6/107 • Number of events 7 • 18-20 weeks
|
|
General disorders
Mucosal inflammation
|
7.5%
8/107 • Number of events 8 • 18-20 weeks
|
8.4%
9/107 • Number of events 10 • 18-20 weeks
|
|
General disorders
Oedema
|
7.5%
8/107 • Number of events 8 • 18-20 weeks
|
3.7%
4/107 • Number of events 4 • 18-20 weeks
|
|
General disorders
Oedema peripheral
|
8.4%
9/107 • Number of events 12 • 18-20 weeks
|
9.3%
10/107 • Number of events 14 • 18-20 weeks
|
|
General disorders
Pyrexia
|
6.5%
7/107 • Number of events 8 • 18-20 weeks
|
13.1%
14/107 • Number of events 17 • 18-20 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
11/107 • Number of events 12 • 18-20 weeks
|
13.1%
14/107 • Number of events 15 • 18-20 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.8%
18/107 • Number of events 22 • 18-20 weeks
|
15.9%
17/107 • Number of events 27 • 18-20 weeks
|
|
Nervous system disorders
Dizziness
|
16.8%
18/107 • Number of events 25 • 18-20 weeks
|
10.3%
11/107 • Number of events 11 • 18-20 weeks
|
|
Nervous system disorders
Headache
|
10.3%
11/107 • Number of events 13 • 18-20 weeks
|
7.5%
8/107 • Number of events 9 • 18-20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
8/107 • Number of events 8 • 18-20 weeks
|
7.5%
8/107 • Number of events 9 • 18-20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.2%
12/107 • Number of events 18 • 18-20 weeks
|
8.4%
9/107 • Number of events 10 • 18-20 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.2%
12/107 • Number of events 14 • 18-20 weeks
|
9.3%
10/107 • Number of events 11 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.6%
21/107 • Number of events 23 • 18-20 weeks
|
15.0%
16/107 • Number of events 19 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.8%
18/107 • Number of events 23 • 18-20 weeks
|
14.0%
15/107 • Number of events 17 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.6%
21/107 • Number of events 25 • 18-20 weeks
|
24.3%
26/107 • Number of events 35 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.6%
6/107 • Number of events 6 • 18-20 weeks
|
1.9%
2/107 • Number of events 2 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.6%
6/107 • Number of events 9 • 18-20 weeks
|
4.7%
5/107 • Number of events 9 • 18-20 weeks
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
6.5%
7/107 • Number of events 7 • 18-20 weeks
|
4.7%
5/107 • Number of events 5 • 18-20 weeks
|
|
Vascular disorders
Epistaxis
|
12.1%
13/107 • Number of events 14 • 18-20 weeks
|
4.7%
5/107 • Number of events 7 • 18-20 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place