Status:
COMPLETED
Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
AstraZeneca
Conditions:
Early-stage Breast Cancer
Eligibility:
FEMALE
50-80 years
Phase:
PHASE3
Brief Summary
Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially c...
Eligibility Criteria
Inclusion
- Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer
- Hormone receptor-positive status
- More than 6 histologically examined lymph nodes
- Laboratory parameters
- hematopoiesis: \> 3500/µl leucocytes, \> 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
- Concluded healing process following surgery
- Less than 4 weeks interval since surgery
- Informed consent
Exclusion
- Premenopausal patients, non-determinable menopausal status
- Previous radiotherapy, chemotherapy or endocrine treatment
- Generalized disease (as verified by lung X-ray, skeletal X-ray, liver ultrasound)
- Contraindications against tamoxifen or anastrozole
- T4 tumors; carcinoma in situ
- Lacking compliance or understanding of disease
- Karnofsky Index \< 3
- Serious concomitant disease
- Septic complications, systemic infections or infectious local processes
- Bilateral ovariectomy or ovarian irradiation
- Second carcinoma or status post second carcinoma (except for 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 :
March 1 2000
Estimated Enrollment :
2021 Patients enrolled
Trial Details
Trial ID
NCT00309491
Start Date
December 1 1990
End Date
March 1 2000
Last Update
October 19 2020
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.