Trial Outcomes & Findings for Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer (NCT NCT01008150)
NCT ID: NCT01008150
Last Updated: 2021-10-25
Results Overview
Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
141 participants
Primary outcome timeframe
At time of surgery, approximately 7 months
Results posted on
2021-10-25
Participant Flow
Participant milestones
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
43
|
12
|
|
Overall Study
COMPLETED
|
42
|
42
|
42
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Overall Study
did not receive study drug
|
1
|
1
|
1
|
0
|
Baseline Characteristics
Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 11.94 • n=4 Participants
|
51.6 years
STANDARD_DEVIATION 10.86 • n=21 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At time of surgery, approximately 7 monthsNumber of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Pathologic Complete Response in Breast and Axillary Lymph Nodes.
|
16 Participants
|
14 Participants
|
21 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At time of surgery, approximately 7 monthsNumber of participants with by no histologic evidence of invasive tumor cells in the surgical breast specimen.
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Pathologic Complete Response in Breast.
|
21 Participants
|
16 Participants
|
22 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At the completion of AC prior to surgery, approximately 7 monthsPopulation: Only patients with palpable disease at baseline are included in this outcome. Arm1-38 patients at baseline, 2 patients missing data. Arm 2-35 patients at baseline, 4 patients missing data. Arm 3-38 patients at baseline, 4 patients missing data. Arm 3 NR-10 patients at baseline, 1 patient missing data.
Upon physical exam the number of participants with resolution of all target and non-target lesions identified at baseline and no new lesions or other signs of disease progression.
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=36 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=31 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=34 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=9 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Clinical Complete Response, as Measured by Physical Exam
|
25 Participants
|
25 Participants
|
28 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with no events of inoperable progressive disease and local, regional and distant recurrence.
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Recurrence-free Interval (RFI)
|
42 Participants
|
39 Participants
|
40 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 24 monthsNumber of participants alive at 24 months.
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Overall Survival
|
42 Participants
|
42 Participants
|
42 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Assessed through 2 years from randomizationPopulation: Refer to Adverse Events section for more details.
Number of patients with at least one adverse event.
Outcome measures
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
n=12 Participants
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Adverse Events Experienced by Participants as a Measure of Toxicity
|
41 Participants
|
42 Participants
|
42 Participants
|
12 Participants
|
Adverse Events
Arm 1: Paclitaxel + Trastuzumab Then A C
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Arm 2: Paclitaxel + Neratinib Then A C
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
n=12 participants at risk
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Infections and infestations
Infection
|
2.4%
1/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Infections and infestations
Erysipelas
|
0.00%
0/42
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Infections and infestations
Neutropenic infection
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Osteomyelitis
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Cystitis
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Device related infection
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
General disorders
Influenza like illness
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
General disorders
Oedema peripheral
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
General disorders
Fatigue
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Vascular disorders
Embolism
|
4.8%
2/42
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Vascular disorders
Haematoma
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Cardiac disorders
Left venrticular dysfunction
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac valve disease
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Nervous system disorders
Syncope
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
Other adverse events
| Measure |
Arm 1: Paclitaxel + Trastuzumab Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Trastuzumab concurrently with paclitaxel weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Following paclitaxel/trastuzumab, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Doxorubicin
Cyclophosphamide
|
Arm 2: Paclitaxel + Neratinib Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on Days 1, 8, and 15 of a 28-day cycle. Neratinib 240 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C
n=42 participants at risk
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
n=12 participants at risk
4 cycles of paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Trastuzumab concurrently with paclitaxel, weekly for a total of 16 doses (4 mg/kg loading dose, then 2 mg/kg weekly). Neratinib 200 mg orally once daily beginning on Day 1 of paclitaxel and continuing through Day 28 of the final cycle of paclitaxel. Following paclitaxel/trastuzumab/neratinib therapy, standard AC every 21 days for 4 cycles. Following surgery, trastuzumab (8 mg/kg loading dose, then 6 mg/kg) every 3 weeks to complete 1 year of targeted therapy (either preoperative trastuzumab therapy or neratinib therapy)
Paclitaxel
Trastuzumab
Neratinib
Doxorubicin
Cyclophosphamide
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
38.1%
16/42
|
100.0%
42/42
|
97.6%
41/42
|
100.0%
12/12
|
|
Gastrointestinal disorders
Nausea
|
28.6%
12/42
|
59.5%
25/42
|
47.6%
20/42
|
66.7%
8/12
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42
|
38.1%
16/42
|
31.0%
13/42
|
50.0%
6/12
|
|
Gastrointestinal disorders
Constipation
|
14.3%
6/42
|
28.6%
12/42
|
26.2%
11/42
|
58.3%
7/12
|
|
Gastrointestinal disorders
Dyspepsia
|
21.4%
9/42
|
31.0%
13/42
|
14.3%
6/42
|
16.7%
2/12
|
|
Gastrointestinal disorders
Stomatitis
|
4.8%
2/42
|
14.3%
6/42
|
16.7%
7/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
3/42
|
7.1%
3/42
|
9.5%
4/42
|
25.0%
3/12
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
1/42
|
4.8%
2/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.1%
3/42
|
0.00%
0/42
|
7.1%
3/42
|
16.7%
2/12
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/42
|
7.1%
3/42
|
7.1%
3/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/42
|
7.1%
3/42
|
4.8%
2/42
|
16.7%
2/12
|
|
Gastrointestinal disorders
Oral pain
|
4.8%
2/42
|
2.4%
1/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/42
|
4.8%
2/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
General disorders
Fatigue
|
42.9%
18/42
|
52.4%
22/42
|
42.9%
18/42
|
66.7%
8/12
|
|
General disorders
Asthenia
|
21.4%
9/42
|
16.7%
7/42
|
23.8%
10/42
|
0.00%
0/12
|
|
General disorders
Pain
|
9.5%
4/42
|
21.4%
9/42
|
11.9%
5/42
|
16.7%
2/12
|
|
General disorders
Pyrexia
|
2.4%
1/42
|
14.3%
6/42
|
14.3%
6/42
|
25.0%
3/12
|
|
General disorders
Oedema peripheral
|
4.8%
2/42
|
11.9%
5/42
|
7.1%
3/42
|
16.7%
2/12
|
|
General disorders
Catheter site pain
|
2.4%
1/42
|
2.4%
1/42
|
2.4%
1/42
|
8.3%
1/12
|
|
General disorders
Influenza like illness
|
2.4%
1/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
General disorders
Chest pain
|
0.00%
0/42
|
0.00%
0/42
|
7.1%
3/42
|
8.3%
1/12
|
|
General disorders
Chills
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
8.3%
1/12
|
|
General disorders
Early satiety
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
General disorders
Mucosal inflammation
|
16.7%
7/42
|
7.1%
3/42
|
19.0%
8/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
47.6%
20/42
|
52.4%
22/42
|
35.7%
15/42
|
50.0%
6/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
9/42
|
21.4%
9/42
|
14.3%
6/42
|
33.3%
4/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.9%
5/42
|
9.5%
4/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.5%
4/42
|
9.5%
4/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.1%
3/42
|
2.4%
1/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/42
|
9.5%
4/42
|
4.8%
2/42
|
25.0%
3/12
|
|
Skin and subcutaneous tissue disorders
Dermatitis aceniform
|
0.00%
0/42
|
7.1%
3/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/42
|
4.8%
2/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/42
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
7/42
|
38.1%
16/42
|
40.5%
17/42
|
58.3%
7/12
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
6/42
|
31.0%
13/42
|
33.3%
14/42
|
58.3%
7/12
|
|
Investigations
Neutraphil count
|
11.9%
5/42
|
14.3%
6/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Investigations
Weight decreased
|
4.8%
2/42
|
14.3%
6/42
|
9.5%
4/42
|
25.0%
3/12
|
|
Investigations
White blood cell count
|
11.9%
5/42
|
9.5%
4/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Investigations
Haemoglobin
|
4.8%
2/42
|
11.9%
5/42
|
4.8%
2/42
|
16.7%
2/12
|
|
Investigations
Alanine aminotransferase
|
4.8%
2/42
|
4.8%
2/42
|
7.1%
3/42
|
8.3%
1/12
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/42
|
4.8%
2/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Investigations
Blood creatinine increased
|
0.00%
0/42
|
2.4%
1/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/42
|
2.4%
1/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Investigations
Neutrophil count decreased
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Investigations
Blood alkaline phosphatase
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/42
|
16.7%
2/12
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
23.8%
10/42
|
16.7%
7/42
|
16.7%
7/42
|
33.3%
4/12
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.0%
8/42
|
19.0%
8/42
|
9.5%
4/42
|
25.0%
3/12
|
|
Nervous system disorders
Dysgeusia
|
7.1%
3/42
|
19.0%
8/42
|
16.7%
7/42
|
25.0%
3/12
|
|
Nervous system disorders
Dizziness
|
9.5%
4/42
|
11.9%
5/42
|
14.3%
6/42
|
33.3%
4/12
|
|
Nervous system disorders
Neurapathy peripheral
|
14.3%
6/42
|
11.9%
5/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Nervous system disorders
Paraesthesia
|
9.5%
4/42
|
9.5%
4/42
|
11.9%
5/42
|
8.3%
1/12
|
|
Nervous system disorders
Neurotoxicity
|
4.8%
2/42
|
2.4%
1/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/42
|
2.4%
1/42
|
9.5%
4/42
|
8.3%
1/12
|
|
Nervous system disorders
Restless leg syndrome
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Nervous system disorders
Dyskinesia
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.0%
13/42
|
21.4%
9/42
|
19.0%
8/42
|
25.0%
3/12
|
|
Blood and lymphatic system disorders
Anaemia
|
21.4%
9/42
|
11.9%
5/42
|
19.0%
8/42
|
16.7%
2/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.9%
5/42
|
14.3%
6/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.4%
1/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
8/42
|
19.0%
8/42
|
16.7%
7/42
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
8/42
|
9.5%
4/42
|
14.3%
6/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
6/42
|
9.5%
4/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
3/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/42
|
2.4%
1/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.8%
2/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/42
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
2/42
|
26.2%
11/42
|
26.2%
11/42
|
16.7%
2/12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
4/42
|
19.0%
8/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/42
|
16.7%
7/42
|
14.3%
6/42
|
50.0%
6/12
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.4%
1/42
|
14.3%
6/42
|
9.5%
4/42
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/42
|
11.9%
5/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehyrdration
|
4.8%
2/42
|
7.1%
3/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/42
|
2.4%
1/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Infection
|
11.9%
5/42
|
4.8%
2/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Infections and infestations
Urinary tract infection
|
9.5%
4/42
|
7.1%
3/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42
|
4.8%
2/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Infections and infestations
Influenza
|
4.8%
2/42
|
0.00%
0/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Infections and infestations
Folliculitis
|
7.1%
3/42
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis
|
4.8%
2/42
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
2/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Infections and infestations
Localised infection
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Infections and infestations
Rhinitis
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
6/42
|
4.8%
2/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42
|
7.1%
3/42
|
4.8%
2/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.9%
5/42
|
0.00%
0/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/42
|
7.1%
3/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42
|
7.1%
3/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
2/42
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Psychiatric disorders
Insomnia
|
19.0%
8/42
|
14.3%
6/42
|
7.1%
3/42
|
25.0%
3/12
|
|
Psychiatric disorders
Anxiety
|
9.5%
4/42
|
11.9%
5/42
|
9.5%
4/42
|
0.00%
0/12
|
|
Psychiatric disorders
Mood altered
|
4.8%
2/42
|
9.5%
4/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
7.1%
3/42
|
14.3%
6/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/42
|
7.1%
3/42
|
7.1%
3/42
|
0.00%
0/12
|
|
Eye disorders
Dry eye
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Eye disorders
Photopsia
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Vascular disorders
Hypertension
|
16.7%
7/42
|
19.0%
8/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Vascular disorders
Embolism
|
0.00%
0/42
|
9.5%
4/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Vascular disorders
Flushing
|
2.4%
1/42
|
4.8%
2/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
0.00%
0/42
|
2.4%
1/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Reproductive system and breast disorders
Breast pain
|
7.1%
3/42
|
7.1%
3/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
2.4%
1/42
|
4.8%
2/42
|
0.00%
0/42
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Immune system disorders
Hypersensitivity
|
4.8%
2/42
|
11.9%
5/42
|
14.3%
6/42
|
8.3%
1/12
|
|
Immune system disorders
Drug hypersensitivity
|
2.4%
1/42
|
0.00%
0/42
|
4.8%
2/42
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/42
|
0.00%
0/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Renal and urinary disorders
Dysuria
|
4.8%
2/42
|
9.5%
4/42
|
2.4%
1/42
|
0.00%
0/12
|
|
Cardiac disorders
Tachycardia
|
2.4%
1/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
2/42
|
0.00%
0/42
|
2.4%
1/42
|
8.3%
1/12
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
1/42
|
2.4%
1/42
|
0.00%
0/42
|
16.7%
2/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/42
|
0.00%
0/42
|
0.00%
0/42
|
8.3%
1/12
|
Additional Information
Director, Department of Regulatory Affairs
NSABP Foundation, Inc
Phone: 412-339-5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60