Trial Outcomes & Findings for Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer (NCT NCT03329378)
NCT ID: NCT03329378
Last Updated: 2023-08-22
Results Overview
Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2 years
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
ddACTHP
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 14.14 • n=93 Participants
|
54.5 years
STANDARD_DEVIATION 15.05 • n=4 Participants
|
49.75 years
STANDARD_DEVIATION 14.75 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy.
Outcome measures
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Number of Participants With Pathologic Complete Response (pCR)
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsDetermination of cardiac toxicity as measured by LVEF, longitudinal strain and troponin. Left ventricular ejection fraction (LVEF) measurement of amount of blood being pumped out of the left ventricle of the heart with each contraction. Peak systolic longitudinal strain is calculated by averaging the values of peak systolic strain in the basal, mid and apical segments of the LV in 4-, 3- and 2-chamber views on echocardiograms. A value of \<-18% or a \>15% decline in strain from patient's baseline value will be used as a cut-off value. A value of troponin I \> 0.08 ng/ml will be considered elevated.
Outcome measures
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Number of Cardiac Toxicity Events
|
2 events
|
2 events
|
SECONDARY outcome
Timeframe: 2 yearsThe frequency of adverse events categorized using CTCAE v4.03
Outcome measures
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Number of Non-cardiac Toxicities
|
63 events
|
120 events
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with breast-conserving surgery for patients for whom mastectomy was planned before treatment. It would be based on surgical opinion at time of surgery if the tumor was appropriately "downstaged" to perform breast conserving surgery on patients previously recommended to have a mastectomy.
Outcome measures
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Number of Participants With Breast Conservation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall Survival - Number of participants alive at the end of the study.
Outcome measures
| Measure |
ddACTHP
n=2 Participants
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 Participants
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Number of Participants Alive at the End of the Study
|
2 Participants
|
5 Participants
|
Adverse Events
ddACTHP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TCHP
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ddACTHP
n=2 participants at risk
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC
Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks
Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Doxorubicin: Doxorubicin 60 mg/m2 IV day 1
Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1
Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15
|
TCHP
n=5 participants at risk
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
Docetaxel: Docetaxel 75mg/m2 IV, day 1
Carboplatin: Carboplatin AUC 6 IV, day 1
Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1
Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1
Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm
Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year
Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Hepatobiliary disorders
ALT increase
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Blood and lymphatic system disorders
ANC decrease
|
50.0%
1/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • 2 years
|
60.0%
3/5 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Hepatobiliary disorders
AST increase
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Cardiac disorders
chest pain
|
100.0%
2/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
Cardiac disorders
cardiac Troponin-I increase
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/2 • 2 years
|
100.0%
5/5 • 2 years
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
dizziness
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Eye disorders
dry eyes
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/2 • 2 years
|
60.0%
3/5 • 2 years
|
|
Nervous system disorders
dysgeusia
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
General disorders
edema- limb
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Cardiac disorders
Ejection fraction decrease
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
General disorders
edema-facial
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
General disorders
fatigue
|
100.0%
2/2 • 2 years
|
80.0%
4/5 • 2 years
|
|
General disorders
fever
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Gatro-esophageal reflux disease
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Vascular disorders
hot flashes
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Blood and lymphatic system disorders
Lymphocyte count decrease
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 2 years
|
80.0%
4/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Parathesia
|
50.0%
1/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
2/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
50.0%
1/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders other, cysts on groin/pelvis area
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 2 years
|
40.0%
2/5 • 2 years
|
|
Blood and lymphatic system disorders
WBC decrease
|
100.0%
2/2 • 2 years
|
60.0%
3/5 • 2 years
|
|
Eye disorders
Watering of eyes
|
0.00%
0/2 • 2 years
|
20.0%
1/5 • 2 years
|
|
Investigations
Weight loss
|
50.0%
1/2 • 2 years
|
0.00%
0/5 • 2 years
|
Additional Information
Dr. Aarti Bhardwaj
Icahn School of Medicine at Mount Sinai
Phone: (212) 824-8578
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place