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

Protocol: 
AAAI1793
Phase: 
III

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

This is 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. The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. Trastuzumab is called a targeted therapy because it targets the tumor cells by blocking the HER2 protein on the surface of the cancer cell to slow down or stop cancer growth. Trastuzumab is a standard treatment for HER2-positive breast cancer. In this study, trastuzumab is considered to be investigational because it has not been studied for use in treating HER2-low breast cancer. Studies that already have been done with trastuzumab focused on breast cancers that were strongly HER2-positive. However, in some of these studies, tumor samples were checked in a central laboratory to confirm the HER2 testing results. Some breast cancers that were thought to be HER2-positive were actually HER2-low. The researchers then looked at the results of treatment in subjects with HER2-low tumors. They found that trastuzumab seemed to have benefit in keeping the cancer from returning even when the HER2 levels were in the normal range. The B-47 study is being done to learn more about using trastuzumab to treat HER2-low breast cancer. A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer. In order to learn more about certain characteristics of cancer tumors, this study includes special research tests that will be done on samples of the tumor that were removed during surgery for breast cancer and on blood samples that will be collected during the study. Another goal of this study is to find out how the drugs used in this study affect menstrual cycles (monthly periods) and if these changes in menstrual cycles have any effect on breast cancer. The B-47 study will also explore the possibility that other medical conditions, medications subjects may be taking, or other factors such as alcohol intake, smoking, and weight may affect breast cancer. Subjects will be asked to complete questionnaires and allow blood samples to be taken to help answer these questions.

Are you Eligible? (Inclusion Criteria)

-Early stage breast cancer that has been removed by surgery
-Patient must be female,
-Patient must be 18 years or older

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States