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

Tracking Information

First Received Date ^ICMJE

March 31, 2006

Last Updated Date

March 31, 2006

Start Date ^ICMJE

December 1990

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Recurrence-free survival
Side-effect profiles

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Phase III Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-Positive Patients

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

Early-Stage Breast Cancer

Intervention ^ICMJE

Drug: Tamoxifen
Drug: Aminoglutethimide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00309491

Responsible Party

Study ID Numbers ^ICMJE

ABCSG-6

Study Sponsor ^ICMJE

Austrian Breast & Colorectal Cancer Study Group

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Raimund Jakesz, MD

Austrian Breast & Colorectal Cancer Study Group

Information Provided By

Austrian Breast & Colorectal Cancer Study Group

Verification Date

December 1995

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP