NCT00493870

TAC Versus TC for Adjuvant Breast Cancer

Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,961 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
DRUG	Doxorubicin	• Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).
DRUG	Cyclophosphamide	600 mg/m2 IV over 15-30 minutes on Day 1.

Timeline

• Start date: 2007-05-29
• Primary completion: 2015-05-31
• Completion: 2020-03-30
• First posted: 2007-06-28
• Last updated: 2023-03-02
• Results posted: 2023-03-02

Locations

95 sites across 1 country: United States