Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer (NCT NCT01998906)

NCT ID: NCT01998906

Last Updated: 2014-10-28

Results Overview

EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

330 participants

Primary outcome timeframe

Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Results posted on

2014-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC) Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C) Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- Doxorubicin/Paclitaxel/CMF (HER2-C) Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Overall Study STARTED	115	116	99
Overall Study COMPLETED	1	2	1
Overall Study NOT COMPLETED	114	114	98

Reasons for withdrawal

Reasons for withdrawal
Measure	HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC) Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C) Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- Doxorubicin/Paclitaxel/CMF (HER2-C) Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Overall Study Participants ongoing in follow-up	77	60	58
Overall Study Death	21	30	17
Overall Study Lack of Efficacy	10	9	8
Overall Study Failure to return	0	2	4
Overall Study Violation of Selection Criteria	0	0	1
Overall Study Withdrawal by Subject	1	4	3
Overall Study Administrative/Other	2	1	3
Overall Study Other	3	8	4

Baseline Characteristics

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=112 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	Total n=326 Participants Total of all reporting groups
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	50.2 years STANDARD_DEVIATION 9.78 • n=5 Participants	52.3 years STANDARD_DEVIATION 10.97 • n=7 Participants	50.6 years STANDARD_DEVIATION 10.46 • n=5 Participants	51.0 years STANDARD_DEVIATION 10.42 • n=4 Participants
Sex: Female, Male Female	115 Participants n=5 Participants	112 Participants n=7 Participants	99 Participants n=5 Participants	326 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.

EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Event-Free Survival (EFS) - Percentage of Participants With an Event	40.0 percentage of participants Interval 47.7 to	50.9 percentage of participants Interval 24.1 to	42.4 percentage of participants Interval 57.7 to

PRIMARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

The median time, in months, between randomization and date of documented occurrence of an EFS event.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Event-Free Survival	NA months Interval 47.7 to Median and upper limit of the 95 percent (%) confidence interval (CI) could not be calculated due to an insufficient number of events at the time of analysis.	43.6 months Interval 24.1 to Upper limit of the 95% CI could not be calculated due to an insufficient number of events at the time of analysis.	64.5 months Interval 57.7 to Upper limit of the 95% CI could not be calculated due to an insufficient number of events at the time of analysis.

PRIMARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Event Free at 1 Year	89 percentage of participants Interval 84.0 to 95.0	82 percentage of participants Interval 74.0 to 89.0	80 percentage of participants Interval 73.0 to 88.0

PRIMARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Event Free at 2 Years	73 percentage of participants Interval 64.0 to 81.0	61 percentage of participants Interval 51.0 to 70.0	69 percentage of participants Interval 60.0 to 78.0

PRIMARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Event Free at 3 Years	65 percentage of participants Interval 56.0 to 74.0	52 percentage of participants Interval 43.0 to 62.0	63 percentage of participants Interval 53.0 to 72.0

SECONDARY outcome

Timeframe: BL, Day 1 of Cycles 1-10 (pre-surgery)

Population: FAS

bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants With Breast Pathological Complete Response (bpCR)	44.3 percentage of participants Interval 35.1 to 53.9	26.7 percentage of participants Interval 18.9 to 35.7	19.2 percentage of participants Interval 12.0 to 28.3

SECONDARY outcome

Timeframe: BL, Day 1 of Cycles 1-10 (pre-surgery)

Population: FAS

tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants With Total Pathological Complete Response (tpCR)	40.0 percentage of participants Interval 31.0 to 49.6	20.7 percentage of participants Interval 13.7 to 29.2	18.2 percentage of participants Interval 11.1 to 27.2

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 of Cycles 1-10

Population: FAS

Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	72.7 percentage of participants Interval 63.4 to 80.8	66.4 percentage of participants Interval 56.6 to 75.2	65.6 percentage of participants Interval 55.2 to 75.0

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

OS was defined as the time from the date of randomization to the date of the death due to any cause.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Overall Survival (OS) - Percentage of Participants With an Event	19.1 percentage of participants	28.4 percentage of participants Interval 58.2 to	21.2 percentage of participants

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

OS was defined as the time from the date of randomization to the date of the death due to any cause.

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Overall Survival	NA months Median and 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.	NA months Interval 58.2 to Median and upper limit of the 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.	NA months Median and 95% CI could not be estimated at the time of data analysis due to the (expected) long survival duration of participants in the trial.

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Surviving at 1 Year	100 percentage of participants Interval 100.0 to 100.0	99 percentage of participants Interval 97.0 to 100.0	97 percentage of participants Interval 93.0 to 100.0

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Surviving at 2 Years	95 percentage of participants Interval 91.0 to 99.0	88 percentage of participants Interval 82.0 to 94.0	90 percentage of participants Interval 83.0 to 96.0

SECONDARY outcome

Timeframe: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Population: FAS

Outcome measures

Outcome measures
Measure	HER2+ TC n=115 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off. Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years.	HER2+ C n=116 Participants Participants with HER2+ breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV and paclitaxel 150 mg/m\^2, IV, on Day 1 followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.	HER2- C n=99 Participants Participants with HER2- breast cancer received treatment as follows: Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m\^2, IV, on Day 1, followed by 2 weeks off. Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m\^2, IV, methotrexate 40 mg/m\^2, IV, and 5-fluorouracil 600 mg/m\^2, IV, on Days 1 and 8, followed by 1 week off.
Percentage of Participants Surviving at 3 Years	85 percentage of participants Interval 79.0 to 92.0	78 percentage of participants Interval 70.0 to 86.0	85 percentage of participants Interval 78.0 to 92.0

Adverse Events

HER2+ TC

Serious events: 18 serious events

Other events: 113 other events

Deaths: 0 deaths

HER2+ C

Serious events: 8 serious events

Other events: 112 other events

Deaths: 0 deaths

HER2- C

Serious events: 9 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER