NCT01275677|CompletedPhase 3ResultsDMC

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2011-02572NSABP-B-47S13-00177CDR0000692574U10CA012027U10CA180868

Study Type

interventional

Target

3,270

Locations

4 countries

Sites

1283

Timeline

RegisteredJan 2011

StartedFeb 2011

CompletionJun 2025

Brief Summary

This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,270

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2011

Longer than P75 for phase_3

Geographic Reach

4 countries

1283 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14.3 years study duration

First Submitted

Initial submission to the registry

January 11, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed

27 days until next milestone

Study Start

First participant enrolled

February 8, 2011

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

September 23, 2020

Completed

4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed

Last Updated

July 14, 2025

Status Verified

June 1, 2025

Enrollment Period

6.5 years

First QC Date

January 11, 2011

Results QC Date

May 6, 2020

Last Update Submit

June 25, 2025

Conditions

HER2/Neu Positive Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

Percentage of Patients Alive and Free From Invasive Disease (IDFS)
Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.
5 years

Secondary Outcomes (6)

Percentage of Patients Alive and Disease-Free (DFS-DCIS)
5 years
Percentage of Patients Alive and Free From Breast Cancer (BCFS)
5 years
Percentage of Patients Alive and Recurrence-Free (RFI)
5 years
Percentage of Patients Alive and Free From Distant Recurrence (DRFI)
5 years
Percentage of Patients Alive (Overall Survival)
5 years
+1 more secondary outcomes

Other Outcomes (2)

Fcgamma Receptor Polymorphism
From baseline to up to 24 months
Change in HER2 mRNA Level
From baseline to 24 months

Study Arms (2)

Arm I (chemotherapy)

ACTIVE COMPARATOR

GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.

Drug: CyclophosphamideDrug: DocetaxelDrug: DoxorubicinDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Quality-of-Life Assessment

Arm II (chemotherapy, trastuzumab)

EXPERIMENTAL

GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.

Drug: CyclophosphamideDrug: DocetaxelDrug: DoxorubicinDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Quality-of-Life AssessmentBiological: Trastuzumab

Interventions

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719