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

Information source: Austrian Breast & Colorectal Cancer Study Group
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Early-Stage Breast Cancer

Intervention: Tamoxifen (Drug); Aminoglutethimide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Austrian Breast & Colorectal Cancer Study Group

Official(s) and/or principal investigator(s):
Raimund Jakesz, MD, Principal Investigator, Affiliation: ABCSG

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.

Clinical Details

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: Overall survival

Secondary outcome:

Recurrence-free survival

Side-effect profiles

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Female.

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)

Locations and Contacts

Additional Information

Starting date: December 1990
Last updated: March 31, 2006

Page last updated: June 20, 2008

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