Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients

• Status: Completed
• Trial end date: 2000-03-01
• Target enrollment: 0
• Participant gender: Female

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 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: Aminoglutethimide; Tamoxifen

Criteria

Inclusion Criteria:

• 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

1. hematopoiesis: > 3500/µl leucocytes, > 100,000/µl 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

• Concluded healing process following surgery

• Less than 4 weeks interval since surgery

• Informed consent

Exclusion Criteria:

• 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)