Docetaxel in Breast Cancer

Summary

Primary objective : * To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : * To compare toxicity and quality of life between the 2 above-mentioned arms. * To evaluate pathologic and molecular markers for predicting efficacy.

Timeline

Start

2001-11

Primary completion

2008-10

Completion

2013-10

Outcome

Missed primary endpoint

registry p = 0.978; Hazard Ratio (HR) 1.00 (95% CI 0.86 to 1.16); Log Rank NCT00312208 ↗

paper The 10-year DFS rates were 66.5% in the AC → T arm and 66.3% in the TAC arm (P = 0.749). PMID 26940688 ↗

Publications

• Blasco A, Lopez-Tarruella S, Urruticoechea A, Carrasco E, Spera G, Martin M, Bermejo B, Chap L, Ruiz-Borrego M, Crown J, Garcia-Saenz JA, Chan A, Guerrero-Zotano A, Semiglazov V, Calvo L, Pienkowski T, Herranz J, Slamon D. Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials. Oncologist. 2025 Sep 1;30(9):oyaf263. doi: 10.1093/oncolo/oyaf263.
• Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.
• Mackey JR, Pienkowski T, Crown J, Sadeghi S, Martin M, Chan A, Saleh M, Sehdev S, Provencher L, Semiglazov V, Press MF, Sauter G, Lindsay M, Houe V, Buyse M, Drevot P, Hitier S, Bensfia S, Eiermann W. Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. Ann Oncol. 2016 Jun;27(6):1041-1047. doi: 10.1093/annonc/mdw098. Epub 2016 Mar 2.

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
Subject	Docetaxel	Small molecule	100 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous

Indications