Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer
Upon determination of eligibility, patients will receive:
Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery
Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin +
Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation
therapy after completion of chemotherapy. Patients with positive estrogen and/or
progesterone receptors will begin anti-estrogen therapy after the last course of
chemotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related toxicities
Denise A. Yardley, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI BRE 69
NCT00193115
March 2004
January 2009
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