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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2021 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-12-31

Study Completion Date

2000-03-31

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.

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Detailed Description

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Conditions

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Early-stage Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I

Tamoxifen alone

Group Type EXPERIMENTAL

Tamoxifen alone

Intervention Type DRUG

2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years

Group II

Tamoxifen + Aminoglutethimide

Group Type EXPERIMENTAL

Tamoxifen alone

Intervention Type DRUG

2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years

Tamoxifen + Aminoglutethimide

Intervention Type DRUG

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

Interventions

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Tamoxifen alone

2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years

Intervention Type DRUG

Tamoxifen + Aminoglutethimide

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

Intervention Type DRUG

Other Intervention Names

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Nolvadex Nolvadex + Orimeten

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

1. hematopoiesis: \> 3500/µl leucocytes, \> 100,000/µl 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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No