Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients

A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-positive, Lymph Node-positive or -Negative Patients

Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free survival, overall survival) in premenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.

Inclusion Criteria:

• Premenopausal patients with histologically verified, lymph node-negative (pT1c-pT3) or lymph node-positive (pT1a-pT3) breast cancer

• Hormone receptor-positive status

• More than 6 histologically examined lymph nodes

• Laboratory parameters

  1. hematopoiesis: > 3500/µl leukocytes, > 100,000/µl thrombocytes
  2. renal function: creatinin < 1.5mg %
  3. hepatic function: GOT </= 2.5 x UNL
  4. bilirubin: < 1.5mg %
  5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
  6. blood coagulation: PZ > 60%

• Concluded healing process following surgery

• </= 4 weeks interval since surgery

• Informed consent

Exclusion Criteria:

• T4 carcinoma; inflammatory breast cancer, carcinoma in situ
• Simultaneous or sequential bilateral breast cancer
• Preoperative tumor-reducing radiotherapy or preoperative tumor-specific medical treatment
• Male patients
• Pregnancy or lactation
• Lacking compliance or understanding of the disease
• General contraindication against cytostatic treatment
• Serious concomitant disease preventing implementation of adjuvant therapy or regular follow-up
• Second carcinoma or status post second carcinoma (except for curatively treated squamous cell carcinoma of the skin or cervical carcinoma in situ)