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 survivalSide-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
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