Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Phase III Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal, Hormone Receptor-positive Patients

Conditions
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Early-stage Breast Cancer

Intervention / Treatment
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* Drug: Tamoxifen alone
* Drug: Tamoxifen + Aminoglutethimide


Participation Criteria
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Eligibility Criteria
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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/µl leucocytes, > 100,000/µl 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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Tamoxifen alone | Drug: Tamoxifen alone<br>* 2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years<br>* Other names: Nolvadex;|
| Experimental: Group II<br>Tamoxifen + Aminoglutethimide | Drug: Tamoxifen alone<br>* 2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years<br>* Other names: Nolvadex;Drug: Tamoxifen + Aminoglutethimide<br>* 2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years) 1st therapy week:125mg/-/125mg Aminoglutethimide daily 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily<br>* Other names: Nolvadex + Orimeten;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  |  | 
| Side-effect profiles |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tamoxifen, Aminoglutethimide, Breast cancer