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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008150
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : December 6, 2018
Last Update Posted : September 11, 2020
Sponsor:
Collaborator:
Puma Biotechnology, Inc.
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Paclitaxel
Drug: Trastuzumab
Drug: Neratinib
Drug: Doxorubicin
Drug: Cyclophosphamide
Enrollment 141
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 43 43 43 12
Completed 42 42 42 12
Not Completed 1 1 1 0
Reason Not Completed
did not receive study drug             1             1             1             0
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 42 42 42 12 138
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 42 participants 12 participants 138 participants
50.1  (9.70) 53.7  (9.87) 50.9  (12.68) 48.7  (11.94) 51.6  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 12 participants 138 participants
Female
42
 100.0%
42
 100.0%
42
 100.0%
12
 100.0%
138
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 12 participants 138 participants
Hispanic or Latino
3
   7.1%
7
  16.7%
4
   9.5%
1
   8.3%
15
  10.9%
Not Hispanic or Latino
38
  90.5%
35
  83.3%
38
  90.5%
8
  66.7%
119
  86.2%
Unknown or Not Reported
1
   2.4%
0
   0.0%
0
   0.0%
3
  25.0%
4
   2.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 42 participants 12 participants 138 participants
White
37
  88.1%
34
  81.0%
38
  90.5%
7
  58.3%
116
  84.1%
Black or African American
3
   7.1%
4
   9.5%
3
   7.1%
2
  16.7%
12
   8.7%
Asian
2
   4.8%
3
   7.1%
1
   2.4%
2
  16.7%
8
   5.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
1
   0.7%
White/American Indian or Alaskan Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   0.7%
1.Primary Outcome
Title Pathologic Complete Response in Breast and Axillary Lymph Nodes.
Hide Description Number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes after neoadjuvant chemotherapy
Time Frame At time of surgery, approximately 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratininb Then AC
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 42 42 42 12
Measure Type: Count of Participants
Unit of Measure: Participants
16
  38.1%
14
  33.3%
21
  50.0%
5
  41.7%
2.Secondary Outcome
Title Pathologic Complete Response in Breast.
Hide Description Number of participants with by no histologic evidence of invasive tumor cells in the surgical breast specimen.
Time Frame At time of surgery, approximately 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 42 42 42 12
Measure Type: Count of Participants
Unit of Measure: Participants
21
  50.0%
16
  38.1%
22
  52.4%
6
  50.0%
3.Secondary Outcome
Title Clinical Complete Response, as Measured by Physical Exam
Hide Description 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.
Time Frame At the completion of AC prior to surgery, approximately 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 36 31 34 9
Measure Type: Count of Participants
Unit of Measure: Participants
25
  69.4%
25
  80.6%
28
  82.4%
6
  66.7%
4.Secondary Outcome
Title Recurrence-free Interval (RFI)
Hide Description Number of participants with no events of inoperable progressive disease and local, regional and distant recurrence.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 42 42 42 12
Measure Type: Count of Participants
Unit of Measure: Participants
42
 100.0%
39
  92.9%
40
  95.2%
12
 100.0%
5.Secondary Outcome
Title Overall Survival
Hide Description Number of participants alive at 24 months.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 42 42 42 12
Measure Type: Count of Participants
Unit of Measure: Participants
42
 100.0%
42
 100.0%
42
 100.0%
12
 100.0%
6.Secondary Outcome
Title Adverse Events Experienced by Participants as a Measure of Toxicity
Hide Description Number of patients with at least one adverse event.
Time Frame Assessed through 2 years from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Refer to Adverse Events section for more details.
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then A C
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 42 42 42 12
Measure Type: Count of Participants
Unit of Measure: Participants
41
  97.6%
42
 100.0%
42
 100.0%
12
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/42 (16.67%)   7/42 (16.67%)   10/42 (23.81%)   2/12 (16.67%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  1/42 (2.38%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Cardiac disorders         
Left venrticular dysfunction  1  1/42 (2.38%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Cardiac valve disease  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Abdominal pain  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Colitis  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Nausea  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Vomiting  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
General disorders         
Pyrexia  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Influenza like illness  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Oedema peripheral  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Fatigue  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Infections and infestations         
Infection  1  1/42 (2.38%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Erysipelas  1  0/42 (0.00%)  1/42 (2.38%)  1/42 (2.38%)  0/12 (0.00%) 
Cellulitis  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Neutropenic infection  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Osteomyelitis  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Bacteraemia  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Cystitis  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Device related infection  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Radiation skin injury  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Hypokalaemia  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Hyponatraemia  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Nervous system disorders         
Syncope  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Depression  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/42 (2.38%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Embolism  1  2/42 (4.76%)  1/42 (2.38%)  1/42 (2.38%)  0/12 (0.00%) 
Haematoma  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Paclitaxel + Trastuzumab Then A C Arm 2: Paclitaxel + Neratinib Then A C Arm 3: Paclitaxel + Trastuzumab + Neratinib Then A C Arm 3 NR: Paclitaxel + Trastuzumab + Neratinib Then AC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/42 (97.62%)   42/42 (100.00%)   42/42 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  13/42 (30.95%)  9/42 (21.43%)  8/42 (19.05%)  3/12 (25.00%) 
Anaemia  1  9/42 (21.43%)  5/42 (11.90%)  8/42 (19.05%)  2/12 (16.67%) 
Leukopenia  1  5/42 (11.90%)  6/42 (14.29%)  2/42 (4.76%)  0/12 (0.00%) 
Lymphopenia  1  1/42 (2.38%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Cardiac disorders         
Tachycardia  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Ear and labyrinth disorders         
Tinnitus  1  2/42 (4.76%)  0/42 (0.00%)  1/42 (2.38%)  1/12 (8.33%) 
Eye disorders         
Vision blurred  1  3/42 (7.14%)  6/42 (14.29%)  1/42 (2.38%)  1/12 (8.33%) 
Conjunctivitis  1  0/42 (0.00%)  3/42 (7.14%)  3/42 (7.14%)  0/12 (0.00%) 
Dry eye  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Lacrimation increased  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Photopsia  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders         
Diarrhoea  1  16/42 (38.10%)  42/42 (100.00%)  41/42 (97.62%)  12/12 (100.00%) 
Nausea  1  12/42 (28.57%)  25/42 (59.52%)  20/42 (47.62%)  8/12 (66.67%) 
Vomiting  1  7/42 (16.67%)  16/42 (38.10%)  13/42 (30.95%)  6/12 (50.00%) 
Constipation  1  6/42 (14.29%)  12/42 (28.57%)  11/42 (26.19%)  7/12 (58.33%) 
Dyspepsia  1  9/42 (21.43%)  13/42 (30.95%)  6/42 (14.29%)  2/12 (16.67%) 
Stomatitis  1  2/42 (4.76%)  6/42 (14.29%)  7/42 (16.67%)  1/12 (8.33%) 
Abdominal Pain  1  3/42 (7.14%)  3/42 (7.14%)  4/42 (9.52%)  3/12 (25.00%) 
Haemorrhoids  1  1/42 (2.38%)  2/42 (4.76%)  4/42 (9.52%)  0/12 (0.00%) 
Abdominal Pain Upper  1  3/42 (7.14%)  0/42 (0.00%)  3/42 (7.14%)  2/12 (16.67%) 
Dry mouth  1  0/42 (0.00%)  3/42 (7.14%)  3/42 (7.14%)  1/12 (8.33%) 
Abdominal distension  1  0/42 (0.00%)  3/42 (7.14%)  2/42 (4.76%)  2/12 (16.67%) 
Oral pain  1  2/42 (4.76%)  1/42 (2.38%)  1/42 (2.38%)  1/12 (8.33%) 
Dysphagia  1  0/42 (0.00%)  2/42 (4.76%)  2/42 (4.76%)  1/12 (8.33%) 
Gastritis  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Flatulence  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Gastrooesophageal reflux disease  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Anorectal discomfort  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Oesophagitis  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Rectal haemorrhage  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
General disorders         
Fatigue  1  18/42 (42.86%)  22/42 (52.38%)  18/42 (42.86%)  8/12 (66.67%) 
Asthenia  1  9/42 (21.43%)  7/42 (16.67%)  10/42 (23.81%)  0/12 (0.00%) 
Pain  1  4/42 (9.52%)  9/42 (21.43%)  5/42 (11.90%)  2/12 (16.67%) 
Pyrexia  1  1/42 (2.38%)  6/42 (14.29%)  6/42 (14.29%)  3/12 (25.00%) 
Oedema peripheral  1  2/42 (4.76%)  5/42 (11.90%)  3/42 (7.14%)  2/12 (16.67%) 
Catheter site pain  1  1/42 (2.38%)  1/42 (2.38%)  1/42 (2.38%)  1/12 (8.33%) 
Influenza like illness  1  1/42 (2.38%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Chest pain  1  0/42 (0.00%)  0/42 (0.00%)  3/42 (7.14%)  1/12 (8.33%) 
Chills  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  1/12 (8.33%) 
Early satiety  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Mucosal inflammation  1  7/42 (16.67%)  3/42 (7.14%)  8/42 (19.05%)  1/12 (8.33%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  1/42 (2.38%)  1/42 (2.38%)  0/42 (0.00%)  2/12 (16.67%) 
Immune system disorders         
Hypersensitivity  1  2/42 (4.76%)  5/42 (11.90%)  6/42 (14.29%)  1/12 (8.33%) 
Drug hypersensitivity  1  1/42 (2.38%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Infections and infestations         
Infection  1  5/42 (11.90%)  2/42 (4.76%)  2/42 (4.76%)  0/12 (0.00%) 
Urinary tract infection  1  4/42 (9.52%)  3/42 (7.14%)  0/42 (0.00%)  0/12 (0.00%) 
Nasopharyngitis  1  3/42 (7.14%)  2/42 (4.76%)  2/42 (4.76%)  1/12 (8.33%) 
Influenza  1  2/42 (4.76%)  0/42 (0.00%)  3/42 (7.14%)  0/12 (0.00%) 
Folliculitis  1  3/42 (7.14%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Sinusitis  1  2/42 (4.76%)  1/42 (2.38%)  1/42 (2.38%)  0/12 (0.00%) 
Upper respiratory tract infection  1  2/42 (4.76%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Onychomycosis  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Localised infection  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  1/12 (8.33%) 
Rhinitis  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications         
Infusion related reaction  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  1/12 (8.33%) 
Investigations         
Alanine aminotransferase increased  1  7/42 (16.67%)  16/42 (38.10%)  17/42 (40.48%)  7/12 (58.33%) 
Aspartate aminotransferase increased  1  6/42 (14.29%)  13/42 (30.95%)  14/42 (33.33%)  7/12 (58.33%) 
Neutraphil count  1  5/42 (11.90%)  6/42 (14.29%)  1/42 (2.38%)  0/12 (0.00%) 
Weight decreased  1  2/42 (4.76%)  6/42 (14.29%)  4/42 (9.52%)  3/12 (25.00%) 
White blood cell count  1  5/42 (11.90%)  4/42 (9.52%)  1/42 (2.38%)  1/12 (8.33%) 
Haemoglobin  1  2/42 (4.76%)  5/42 (11.90%)  2/42 (4.76%)  2/12 (16.67%) 
Alanine aminotransferase  1  2/42 (4.76%)  2/42 (4.76%)  3/42 (7.14%)  1/12 (8.33%) 
Blood alkaline phosphatase increased  1  0/42 (0.00%)  2/42 (4.76%)  3/42 (7.14%)  0/12 (0.00%) 
Blood creatinine increased  1  0/42 (0.00%)  1/42 (2.38%)  4/42 (9.52%)  0/12 (0.00%) 
Gamma-glutamyltransferase increased  1  0/42 (0.00%)  1/42 (2.38%)  4/42 (9.52%)  0/12 (0.00%) 
Neutrophil count decreased  1  2/42 (4.76%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Blood alkaline phosphatase  1  1/42 (2.38%)  2/42 (4.76%)  0/42 (0.00%)  2/12 (16.67%) 
Ejection fraction decreased  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Blood bilirubin increased  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/42 (4.76%)  11/42 (26.19%)  11/42 (26.19%)  2/12 (16.67%) 
Hyperglycaemia  1  4/42 (9.52%)  8/42 (19.05%)  3/42 (7.14%)  0/12 (0.00%) 
Hypokalaemia  1  1/42 (2.38%)  7/42 (16.67%)  6/42 (14.29%)  6/12 (50.00%) 
Hyponatraemia  1  1/42 (2.38%)  6/42 (14.29%)  4/42 (9.52%)  1/12 (8.33%) 
Hypocalcaemia  1  1/42 (2.38%)  5/42 (11.90%)  4/42 (9.52%)  0/12 (0.00%) 
Dehyrdration  1  2/42 (4.76%)  3/42 (7.14%)  1/42 (2.38%)  1/12 (8.33%) 
Hypomagnesaemia  1  0/42 (0.00%)  1/42 (2.38%)  3/42 (7.14%)  0/12 (0.00%) 
Hypernatraemia  1  2/42 (4.76%)  1/42 (2.38%)  0/42 (0.00%)  0/12 (0.00%) 
Hypoalbuminaemia  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Hypoproteinaemia  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Hyperkalaemia  1  0/42 (0.00%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/42 (14.29%)  2/42 (4.76%)  3/42 (7.14%)  0/12 (0.00%) 
Myalgia  1  4/42 (9.52%)  3/42 (7.14%)  2/42 (4.76%)  1/12 (8.33%) 
Musculoskeletal pain  1  5/42 (11.90%)  0/42 (0.00%)  3/42 (7.14%)  0/12 (0.00%) 
Back pain  1  0/42 (0.00%)  3/42 (7.14%)  4/42 (9.52%)  0/12 (0.00%) 
Muscular weakness  1  1/42 (2.38%)  3/42 (7.14%)  1/42 (2.38%)  0/12 (0.00%) 
Neck pain  1  2/42 (4.76%)  1/42 (2.38%)  1/42 (2.38%)  0/12 (0.00%) 
Bone pain  1  3/42 (7.14%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Pain in extremity  1  1/42 (2.38%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Musculoskeletal chest pain  1  1/42 (2.38%)  1/42 (2.38%)  0/42 (0.00%)  1/12 (8.33%) 
Flank pain  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Muscle tightness  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Pain in jaw  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumor pain  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Nervous system disorders         
Headache  1  10/42 (23.81%)  7/42 (16.67%)  7/42 (16.67%)  4/12 (33.33%) 
Peripheral sensory neuropathy  1  8/42 (19.05%)  8/42 (19.05%)  4/42 (9.52%)  3/12 (25.00%) 
Dysgeusia  1  3/42 (7.14%)  8/42 (19.05%)  7/42 (16.67%)  3/12 (25.00%) 
Dizziness  1  4/42 (9.52%)  5/42 (11.90%)  6/42 (14.29%)  4/12 (33.33%) 
Neurapathy peripheral  1  6/42 (14.29%)  5/42 (11.90%)  3/42 (7.14%)  0/12 (0.00%) 
Paraesthesia  1  4/42 (9.52%)  4/42 (9.52%)  5/42 (11.90%)  1/12 (8.33%) 
Neurotoxicity  1  2/42 (4.76%)  1/42 (2.38%)  3/42 (7.14%)  0/12 (0.00%) 
Hypoaesthesia  1  0/42 (0.00%)  1/42 (2.38%)  4/42 (9.52%)  1/12 (8.33%) 
Restless leg syndrome  1  2/42 (4.76%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Cranial nerve disorder  1  0/42 (0.00%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Dyskinesia  1  1/42 (2.38%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Insomnia  1  8/42 (19.05%)  6/42 (14.29%)  3/42 (7.14%)  3/12 (25.00%) 
Anxiety  1  4/42 (9.52%)  5/42 (11.90%)  4/42 (9.52%)  0/12 (0.00%) 
Mood altered  1  2/42 (4.76%)  4/42 (9.52%)  1/42 (2.38%)  0/12 (0.00%) 
Depression  1  1/42 (2.38%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Depressed mood  1  0/42 (0.00%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Renal and urinary disorders         
Dysuria  1  2/42 (4.76%)  4/42 (9.52%)  1/42 (2.38%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Breast pain  1  3/42 (7.14%)  3/42 (7.14%)  2/42 (4.76%)  0/12 (0.00%) 
Vaginal inflammation  1  1/42 (2.38%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Pelvic pain  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  8/42 (19.05%)  8/42 (19.05%)  7/42 (16.67%)  1/12 (8.33%) 
Cough  1  8/42 (19.05%)  4/42 (9.52%)  6/42 (14.29%)  0/12 (0.00%) 
Dyspnoea  1  6/42 (14.29%)  4/42 (9.52%)  2/42 (4.76%)  0/12 (0.00%) 
Rhinorrhoea  1  3/42 (7.14%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Oropharyngeal pain  1  0/42 (0.00%)  1/42 (2.38%)  3/42 (7.14%)  0/12 (0.00%) 
Dyspnoea exertional  1  2/42 (4.76%)  0/42 (0.00%)  2/42 (4.76%)  0/12 (0.00%) 
Dysphonia  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Rhinitis allergic  1  0/42 (0.00%)  1/42 (2.38%)  2/42 (4.76%)  0/12 (0.00%) 
Productive Cough  1  2/42 (4.76%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Atelectasis  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  20/42 (47.62%)  22/42 (52.38%)  15/42 (35.71%)  6/12 (50.00%) 
Rash  1  9/42 (21.43%)  9/42 (21.43%)  6/42 (14.29%)  4/12 (33.33%) 
Pruritus  1  5/42 (11.90%)  4/42 (9.52%)  2/42 (4.76%)  1/12 (8.33%) 
Acne  1  4/42 (9.52%)  4/42 (9.52%)  1/42 (2.38%)  0/12 (0.00%) 
Nail disorder  1  3/42 (7.14%)  1/42 (2.38%)  3/42 (7.14%)  0/12 (0.00%) 
Dry skin  1  0/42 (0.00%)  4/42 (9.52%)  2/42 (4.76%)  3/12 (25.00%) 
Dermatitis aceniform  1  0/42 (0.00%)  3/42 (7.14%)  2/42 (4.76%)  1/12 (8.33%) 
Erythema  1  0/42 (0.00%)  2/42 (4.76%)  2/42 (4.76%)  1/12 (8.33%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/42 (2.38%)  2/42 (4.76%)  0/42 (0.00%)  0/12 (0.00%) 
Exfoliative rash  1  0/42 (0.00%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Skin fissures  1  0/42 (0.00%)  1/42 (2.38%)  2/42 (4.76%)  0/12 (0.00%) 
Palmar erythema  1  2/42 (4.76%)  0/42 (0.00%)  0/42 (0.00%)  0/12 (0.00%) 
Skin disorder  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  1/12 (8.33%) 
Rash generalised  1  0/42 (0.00%)  0/42 (0.00%)  0/42 (0.00%)  1/12 (8.33%) 
Skin hyperpigmentation  1  0/42 (0.00%)  0/42 (0.00%)  1/42 (2.38%)  1/12 (8.33%) 
Vascular disorders         
Hypertension  1  7/42 (16.67%)  8/42 (19.05%)  2/42 (4.76%)  0/12 (0.00%) 
Embolism  1  0/42 (0.00%)  4/42 (9.52%)  1/42 (2.38%)  1/12 (8.33%) 
Flushing  1  1/42 (2.38%)  2/42 (4.76%)  1/42 (2.38%)  0/12 (0.00%) 
Hypotension  1  0/42 (0.00%)  1/42 (2.38%)  0/42 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diana Gosik
Organization: NSABP Foundation, Inc
Phone: 412-339-5333
EMail: diana.gosik@nsabp.org
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01008150    
Other Study ID Numbers: NSABP FB-7
First Submitted: November 3, 2009
First Posted: November 5, 2009
Results First Submitted: November 5, 2018
Results First Posted: December 6, 2018
Last Update Posted: September 11, 2020