Overview

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

-
- 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)