Status:
COMPLETED
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
Lead Sponsor:
Medical College and Hospital Kolkata
Conditions:
Benign Breast Disease
Fibrocystic Disease of Breast
Eligibility:
FEMALE
16+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiolo...
Detailed Description
Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is ...
Eligibility Criteria
Inclusion
- Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
- Benign Breast disease amenable to hormonal therapy.
Exclusion
- Postmenopausal women.
- Premenopausal women with pregnancy or other contraindications to tamoxifen.
- Girls less than 16 years.
- Very large lesions which require surgery for cosmesis.
- High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.
- Lesions like duct ectasia where hormone therapy is not likely to be of benefit.
- Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.
- Patients unwilling to undergo treatment.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00999921
Start Date
January 1 2008
End Date
January 1 2015
Last Update
May 18 2015
Active Locations (1)
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1
Department of Surgery, Medical College, Kolkata
Kolkata, West Bengal, India, 700073