Randomized Study Comparing Tamoxifen Vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-Positive Patients
This study has been completed.
Sponsor:
Austrian Breast & Colorectal Cancer Study Group
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
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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:
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
- hematopoiesis: > 3500/l leukocytes, > 100,000/l thrombocytes
- renal function: creatinin < 1.5mg%
- hepatic function: GOT 2.5 x UNL
- bilirubin: < 1.5mg %
- 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 More Information
Additional Information:
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 May 21, 2013