TAC Versus TC for Adjuvant Breast Cancer

Phase 3 Completed 1961 enrolled US Oncology Research Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2007-05-29
Primary completion: 2015-05-31
Completion: 2020-03-30

Outcome

Missed primary endpoint

paper the primary end point of the ABC trials, remains consistent with the original results, as noninferiority of the nonanthracycline regimens could not be declared PMID 38335467 ↗

Publications

Geyer CE Jr, Blum JL, Yothers G, Asmar L, Flynn PJ, Robert NJ, Hopkins JO, O'Shaughnessy JA, Rastogi P, Puhalla SL, Hilton CJ, Dang CT, Gomez HL, Vukelja SJ, Lyss AP, Paul D, Brufsky AM, Colangelo LH, Swain SM, Mamounas EP, Wolmark N. Long-Term Follow-Up of the Anthracyclines in Early Breast Cancer Trials (USOR 06-090, NSABP B-46-I/USOR 07132, and NSABP B-49 [NRG Oncology]). J Clin Oncol. 2024 Apr 20;42(12):1344-1349. doi: 10.1200/JCO.23.01428. Epub 2024 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Subject	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Comparator	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous