Trial Outcomes & Findings for Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (NCT NCT02654119)
NCT ID: NCT02654119
Last Updated: 2026-03-23
Results Overview
Number of participants who experienced Neutropenia.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=20 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Age, Continuous
|
56.10 years
STANDARD_DEVIATION 11.06 • n=10 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).Number of participants who experienced Neutropenia.
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number Participants With Neutropenia, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4.03
|
2 Participants
|
PRIMARY outcome
Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).Number of Participants experienced paclitaxel-related neuropathy and adverse events
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number of Participants With Paclitaxel-related Neuropathy, Graded According to the NCI CTCAE v4.03
Related to Investigational Product
|
1 Participants
|
|
Number of Participants With Paclitaxel-related Neuropathy, Graded According to the NCI CTCAE v4.03
Probably Related Investigational Product
|
14 Participants
|
PRIMARY outcome
Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).Participants experienced grade 3/4 cardiotoxicity with standard treatment
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number of Participants With Cardiotoxicity Grade 3/4 Cardiotoxicity, Graded According to the NCI CTCAE v4.03
|
2 Participants
|
PRIMARY outcome
Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).Participants that experienced grade 3/4 nausea/vomiting with this regimen when compared to standard regimens.
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number of Participants With Grade 3/4 Nausea/Vomiting, Graded According to the NCI CTCAE v4.03
|
0 Participants
|
PRIMARY outcome
Timeframe: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed at 2 yearsRFS and survival curves will be plotted following the method of Kaplan and Meier using the full analysis set.
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number of Participants With Recurrence Free Survival (RFS)
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsNumber of participants with inability to complete treatment, defined as a patient that requires a lower dose of therapy (defined as dose lowered by 50%), or a postponement of scheduled treatment of longer than 28 days, or discontinuation of treatment for any reason. will be described using frequencies and proportions and 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 Participants
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Number of Participants With Inability to Complete Treatment, Defined as a Patient That Requires a Lower Dose of Therapy (Defined as Dose Lowered by 50%), or a Postponement of Scheduled Treatment of Longer Than 28 Days, or Discontinuation for Any Reason
|
3 Participants
|
Adverse Events
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 participants at risk
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.5%
2/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Fever
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
Other adverse events
| Measure |
Treatment (Cyclophosphamide, Paclitaxel, Trastuzumab)
n=19 participants at risk
SYSTEMIC THERAPY: Patients receive cyclophosphamide IV over 1 hour, paclitaxel IV over 3 hours, and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE TRASTUZUMAB THERAPY: Beginning in course 6, patients receive trastuzumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients may undergo radiation therapy at the discretion of the radiation oncologist and medical oncologist and patients with estrogen/progesterone receptor positive tumors receive hormonal therapy as determined by the medical oncologist per standard NCCN guidelines.
Cyclophosphamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Trastuzumab: Given IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Infections and infestations
Vaginal infection
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Infections and infestations
Wound infection
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
89.5%
17/19 • Number of events 57 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
84.2%
16/19 • Number of events 40 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
fatigue
|
68.4%
13/19 • Number of events 20 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Alkaline phosphatase increased
|
63.2%
12/19 • Number of events 19 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
63.2%
12/19 • Number of events 17 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
White blood cell decreased
|
52.6%
10/19 • Number of events 18 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
47.4%
9/19 • Number of events 13 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
47.4%
9/19 • Number of events 23 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
42.1%
8/19 • Number of events 10 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Vascular disorders
Flushing
|
42.1%
8/19 • Number of events 9 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
42.1%
8/19 • Number of events 8 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
36.8%
7/19 • Number of events 18 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
36.8%
7/19 • Number of events 11 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.8%
7/19 • Number of events 8 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
36.8%
7/19 • Number of events 11 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Vascular disorders
Hot flashes
|
36.8%
7/19 • Number of events 9 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Edema limbs
|
31.6%
6/19 • Number of events 8 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
26.3%
5/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
26.3%
5/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
21.1%
4/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.1%
4/19 • Number of events 6 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.1%
4/19 • Number of events 9 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.1%
4/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Pain
|
21.1%
4/19 • Number of events 13 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Psychiatric disorders
Depression
|
15.8%
3/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
15.8%
3/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
15.8%
3/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Fever
|
15.8%
3/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
3/19 • Number of events 5 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.8%
3/19 • Number of events 6 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.8%
3/19 • Number of events 6 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
15.8%
3/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Psychiatric disorders
Restlessness
|
15.8%
3/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
3/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Weight gain
|
15.8%
3/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Cardiac disorders
Ejection fraction decreased
|
10.5%
2/19 • Number of events 4 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Eye disorders
Eye disorders
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Psychiatric disorders
Personality change
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Platelet count decreased
|
10.5%
2/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Scalp pain
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
10.5%
2/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
10.5%
2/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.5%
2/19 • Number of events 3 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Immune system disorders
Allergic reaction
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Chills
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Concentration impairment
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Investigations
Creatinine increased
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
General disorders
Edema trunk
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Eye disorders
Eye pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Facial pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.3%
1/19 • Number of events 2 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Infections and infestations
Nail infection
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Ear and labyrinth disorders
Otitis externa
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.3%
1/19 • Number of events 1 • From initiation of study treatment through completion of study therapy (approximately 52 weeks including trastuzumab maintenance) and continuing for up to 3 months following the final dose of study treatment.
|
Additional Information
Dr. Amulya Yellala
University of Nebraska Medical Center
Phone: 402-559-5388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place