Status:
COMPLETED
Randomized Study Comparing CMF and Goserelin + Tamoxifen in Premenopausal Receptor-positive Patients
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
AstraZeneca
Conditions:
Early-stage Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
Brief Summary
Primarily, this clinical investigation compared the efficacy of cyclophosphamide + methotrexate + fluorouracil chemotherapy vs. goserelin + tamoxifen treatment in terms of prognosis (disease-free surv...
Eligibility Criteria
Inclusion
- 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
- hematopoiesis: \> 3500/µl leukocytes, \> 100,000/µl thrombocytes
- renal function: creatinin \< 1.5mg %
- hepatic function: GOT \</= 2.5 x UNL
- bilirubin: \< 1.5mg %
- metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
- blood coagulation: PZ \> 60%
- Concluded healing process following surgery
- \</= 4 weeks interval since surgery
- Informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 1990
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
1099 Patients enrolled
Trial Details
Trial ID
NCT00309478
Start Date
December 1 1990
End Date
June 1 2004
Last Update
June 29 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.