A Randomized Phase III Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-Positive Patients
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/l leukocytes, > 100,000/l 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)