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Randomized Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-Positive Patients

This study has been completed.
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309491
First received: March 31, 2006
Last updated: NA
Last verified: December 1995
History: No changes posted
  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
Drug: Aminoglutethimide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Estimated Enrollment: 2000
Study Start Date: December 1990
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders 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/l leukocytes, > 100,000/l 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 ClinicalTrials.gov identifier: 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:
No publications provided by Austrian Breast & Colorectal Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00309491     History of Changes
Other Study ID Numbers: ABCSG-6
Study First Received: March 31, 2006
Last Updated: March 31, 2006
Health Authority: Austria: Federal Ministry for Health and Women

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Aminoglutethimide
Tamoxifen
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014