drugset / Trial / NCT02613026
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
Timeline
- Start
- 2009-07
- Primary completion
- 2013-03
- Completion
- 2015-02
Publications
- Background Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. doi: 10.1200/JCO.2005.02.6187.
- Background Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
- Background Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Other |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | Other |
| Subject | Pirarubicin | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Pirarubicin | Small molecule | 60 mg/m2 | Intravenous |