CompletedPhase 4

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

India256 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)

Timeframe: 3 months

Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).

Timeframe: 3 months

Trial details

NCT IDNCT00999921

SponsorMedical College and Hospital Kolkata

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2010-11-15

View on ClinicalTrials.gov More Benign Breast Disease trials