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

A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients

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.

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)