Trial ID or NCT#

NCT01275677

Status

NOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Douglas W. Blayney, MD, FACP
Medical oncologist, Breast specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Frank E. Stockdale, MD, PhD
Medical oncologist, Breast specialist
Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus
Robert W. Carlson
Irene Wapnir
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery) at the Stanford University Medical Center

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CONTACT

CCTO
(650) 498-7061