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

Medical College and Hospital Kolkata

Status and phase

Completed

Phase 4

Conditions

Fibroadenoma

Fibrocystic Disease of Breast

Benign Breast Disease

Mastalgia

Treatments

Drug: Evening Primrose Oil

Drug: Tamoxifen

Study type

Interventional

Funder types

Other

Identifiers

NCT00999921

MSVP-107/08

Details and patient eligibility

About

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.

Full 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 not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Enrollment

256 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.