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NSABP Clinical Trials Overview

Protocol B-20
A Clinical Trial to Determine the Worth of Chemotherapy and Tamoxifen over Tamoxifen Alone in the Management of Patients with Primary Invasive Breast Cancer, Negative Axillary Nodes and Estrogen-Receptor-Positive Tumors

Specific Aims
The aims of this study are twofold: to determine whether the addition of combination chemotherapy will improve the benefit of tamoxifen in this group of patients, and, if so, to determine whether an alkylating agent is required when the chemotherapy is given with tamoxifen.

Specifically, the study goals are:
  1. to determine whether six cycles of sequential methotrexate and 5-fluorouracil (M→F) followed by leucovorin, when added to tamoxifen (M→F+T), are more effective than tamoxifen alone;
  2. to determine whether six cycles of cyclophosphamide, methotrexate and 5-fluorouracil (CMF), when added to tamoxifen (CMF+T), are more effective than tamoxifen;
  3. to determine whether CMF+T is more effective than M→F+T. End points for evaluation of treatment effectiveness include survival and disease-free survival.
A secondary objective is to relate tumor cell ploidy, kinetics, and nuclear grade to patient outcome.