Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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 etiology and estrogen receptor status and to realize its side-effects and cost of therapy.

To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College and Hospital Kolkata
• Treatments: Efamol; Evening primrose oil; Tamoxifen

Criteria

Inclusion Criteria:

• Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.

• Benign Breast disease amenable to hormonal therapy.

Exclusion Criteria:

• 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.