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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309491
First Posted: April 3, 2006
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309491


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00309491     History of Changes
Other Study ID Numbers: ABCSG-6
First Submitted: March 31, 2006
First Posted: April 3, 2006
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Tamoxifen
Aminoglutethimide
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