A Randomized Phase III Study Comparing Cyclophosphamide + Methotrexate + Fluorouracil Vs. Goserelin + Tamoxifen in Premenopausal, Hormone Receptor-Positive, Lymph Node-Positive or -Negative Patients
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/l leukocytes, > 100,000/l 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)