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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborator: AstraZeneca
• Treatments: Cyclophosphamide; Fluorouracil; Goserelin; Methotrexate; Tamoxifen

Criteria

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

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

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• 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)