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

Phase 4

Completed

Conditions: Benign Breast Disease
Fibrocystic Disease of Breast
Mastalgia
Fibroadenoma

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 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.

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 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen	10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
Evening Primrose Oil	Evening Primrose Oil	1000 mg daily for 3 months

Primary Outcome Measures

Name	Time	Method
Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)	3 months	Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.
Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).	3 months	All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response

Secondary Outcome Measures

Name	Time	Method
Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)	3 months	All patients who had an increase in breast pain in the "perimenstrual period" were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia