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

Phase 3

Completed

• Conditions: Early-stage Breast Cancer
• Interventions: Drug: Tamoxifen alone; Drug: Tamoxifen + Aminoglutethimide

• Registration Number: NCT00309491
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

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 curative, operated hormone receptor-positive breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 1990-12
• Primary Completion: 1996-01
• Study Completion: 2000-03
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2021

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Tamoxifen alone	Tamoxifen alone
Group II	Tamoxifen + Aminoglutethimide	Tamoxifen + Aminoglutethimide
Group II	Tamoxifen alone	Tamoxifen + Aminoglutethimide

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival
Side-effect profiles