Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
Austrian Breast & Colorectal Cancer Study Group Identifier:
First received: March 31, 2006
Last updated: April 8, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Early-stage Breast Cancer
Drug: Tamoxifen alone
Drug: Tamoxifen + Aminoglutethimide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients

Resource links provided by NLM:

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Recurrence-free survival
  • Side-effect profiles

Enrollment: 2020
Study Start Date: December 1990
Arms Assigned Interventions
Experimental: Group I
Tamoxifen alone
Drug: Tamoxifen alone
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
Other Name: Nolvadex
Experimental: Group II
Tamoxifen + Aminoglutethimide
Drug: Tamoxifen alone
2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years
Other Name: Nolvadex
Drug: Tamoxifen + Aminoglutethimide

2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years)

  • 1st therapy week:125mg/-/125mg Aminoglutethimide daily
  • 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily
  • as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily
Other Name: Nolvadex + Orimeten


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00309491

Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
Publications: Identifier: NCT00309491     History of Changes
Other Study ID Numbers: ABCSG-6 
Study First Received: March 31, 2006
Last Updated: April 8, 2016
Health Authority: Austria: Federal Ministry for Health and Women
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016