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Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients
The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.
Both TAC (docetaxel, doxorubicin, and cyclophosphamide) and TC (docetaxel and cyclophosphamide) are established adjuvant chemotherapy regimens for early stage breast cancer. TAC, however, due to the inclusion of the anthracycline doxorubicin, carries a high risk of hematologic and cardiotoxic adverse effects. Substantial evidence supports the concept that early stage HER2-negative breast cancers will benefit similarly from anthracycline-based adjuvant and non-anthracycline-based chemotherapy. Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A gene, which may predict for benefit from anthracycline-based chemotherapy. We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients, it would not only be an important advance in the understanding of the biology of cancer, but it would also be of significant clinical benefit to women with breast cancer.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern AZ Hematology Oncology Associates-AOA
Sedona, Arizona, United States
Arizona Oncology Associates DBA HOPE
Tucson, Arizona, United States
Central Hematology Oncology Medical Group, Inc.
Alhambra, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St. Jude Hertiage Medical Group
Fullerton, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Antelope Valley Cancer Center
Lancaster, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
Start Date
May 29, 2007
Primary Completion Date
May 31, 2015
Completion Date
March 30, 2020
Last Updated
March 2, 2023
1,961
ACTUAL participants
Docetaxel
DRUG
Doxorubicin
DRUG
Cyclophosphamide
DRUG
Lead Sponsor
US Oncology Research
Collaborators
NCT05245812
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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