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

This study has been completed.

First Received on March 31, 2006. No Changes Posted

Sponsor:	Austrian Breast & Colorectal Cancer Study Group
Information provided by:	Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00309491

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 III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Aminoglutethimide

U.S. FDA Resources

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aminoglutethimide
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 09, 2012