Adjuvant endocrine therapy, cytotoxic chemotherapy and immunotherapy in stage II breast cancer: 6-year result

J Steroid Biochem. 1985 Dec;23(6B):1147-50. doi: 10.1016/0022-4731(85)90034-2.


Six-year results of a prospective, randomized clinical trial of three treatment regimens [(1) cytoxan, methotrexate and 5-fluorouracil (CMF); (2) CMF plus the antiestrogen drug, tamoxifen (CMFT); (3) CMFT plus Bacillus Calmette-Guerin (BCG) vaccinations] in 312 women with stage II breast cancer are reported. Addition of tamoxifen to CMF therapy significantly decreased the number of recurrences at 6 years in ER + patients with greater than or equal to 4 positive axillary lymph nodes, and in those with tumor diameter in excess of 3 cm. The beneficial effect of tamoxifen appeared to be independent of the menopausal status. Addition of tamoxifen to CMF had no effect on disease-free survival in ER + patients with 1-3 positive axillary lymph nodes or in patients with ER--tumors. Addition of BCG vaccinations had no discernible effect on disease-free survival. ER measurements in the primary tumor provide important prognostic information regardless of treatment, with ER + patients having increased overall survival after 6 years. Further follow-up is needed to determine whether tamoxifen is delaying recurrence or preventing it in a subset of these patients.

Publication types

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

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • BCG Vaccine / therapeutic use
  • Breast Neoplasms / therapy*
  • Clinical Trials as Topic
  • Combined Modality Therapy
  • Cyclophosphamide / therapeutic use
  • Female
  • Fluorouracil / therapeutic use
  • Humans
  • Immunotherapy*
  • Mastectomy
  • Menopause
  • Methotrexate / therapeutic use
  • Random Allocation
  • Receptors, Estrogen / analysis
  • Tamoxifen / therapeutic use
  • Time Factors


  • BCG Vaccine
  • Receptors, Estrogen
  • Tamoxifen
  • Cyclophosphamide
  • Fluorouracil
  • Methotrexate

Supplementary concepts

  • CMF regimen