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

Austrian Breast & Colorectal Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Early-stage Breast Cancer

Treatments: Drug: Tamoxifen alone; Drug: Tamoxifen + Aminoglutethimide

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00309491

ABCSG-6

Details and patient eligibility

About

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.

Enrollment: 2,021 patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,021 participants in 2 patient groups

Group I

Experimental group

Description:

Tamoxifen alone

Treatment:

Drug: Tamoxifen alone

Group II

Experimental group

Description:

Tamoxifen + Aminoglutethimide

Treatment:

Drug: Tamoxifen alone

Drug: Tamoxifen + Aminoglutethimide