Phase 4
N=256
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
Benign Breast Disease · Fibrocystic Disease of Breast · Fibroadenoma · Mastalgia
Bottom Line
View on ClinicalTrials.gov: NCT00999921 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) — 63; 61; 54; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tamoxifen (Drug); Evening Primrose Oil (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Medical College and Hospital Kolkata
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response) |
63; 61; 54; 14; 9; 47 | — |
| PRIMARY Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score). |
71; 10; 13; 15; 3; 11 | — |
| SECONDARY Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia) |
37; 36; 30; 11; 7; 25 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00999921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.