Treatment of advanced breast cancer with cyclophosphamide, 5-fluorouracil, and prednisone with and without methanol-extracted residue of BCG

Cancer Clin Trials. Winter 1979;2(4):345-50.


The value of immunotherapy as an adjuvant to chemotherapy for advanced breast cancer is an unsettled question. To clarify this issue, 71 women with measurable or evaluable metastatic breast cancer were randomized to receive cyclophosphamide, 5-fluorouracil, and prednisone (CFP) with or without methanol-extracted residue of Bacillus Calmette-Guerin (MER). The total regression rates were 52% (CFP) and 39% (CFP + MER), including complete regression rates of 13% (CFP) and 65% (CFP + MER). The median duration of regressions for CFP-treated patients was 257-261 days and for CFP + MER-treated patients was 385 days. The median time to progression was 248-261 days in the CFP group and 159 days in the CFP-MER group. Projected median survival for both treatment groups is 20 months. Immunotherapy (MER) as used in this study does not appear to augment regression rates or vurvival for patients with advanced breast cancer receiving CFP.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • BCG Vaccine / therapeutic use*
  • Bone Marrow / drug effects
  • Breast Neoplasms / therapy*
  • Clinical Trials as Topic
  • Cyclophosphamide / administration & dosage
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Middle Aged
  • Prednisone / administration & dosage
  • Remission, Spontaneous
  • Time Factors


  • Antineoplastic Agents
  • BCG Vaccine
  • Cyclophosphamide
  • Fluorouracil
  • Prednisone