Clinical trial · Interventional
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
A Single Blinded Randomized Controlled Trial of the Comparative Effects of Tamoxifen and Evening Primrose Oil in Premenopausal Non-high Risk Patients With Benign Breast Disease With Respect to the Estrogen Receptor Status.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Disease | — | UNRESOLVED | — |
| Fibroadenoma | Breast Fibroadenoma | ALIAS | 0.90 |
| Fibrocystic Disease of Breast | — | UNRESOLVED | — |
| Mastalgia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evening Primrose Oil | Drug | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
- interventionNames
- Drug: Tamoxifen
- type
- EXPERIMENTAL
- label
- Evening Primrose Oil
- description
- 1000 mg daily for 3 months
- interventionNames
- Drug: Evening Primrose Oil
Primary outcomes (2)
- measure
- Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDSrivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16. PMID 17509880
- BACKGROUNDAllegra JC, Lippman ME, Green L, Barlock A, Simon R, Thompson EB, Huff KK, Griffin W. Estrogen receptor values in patients with benign breast disease. Cancer. 1979 Jul;44(1):228-31. doi: 10.1002/1097-0142(197907)44:13.0.co;2-0. PMID 455247
- BACKGROUNDHurst JL, Mega JF, Hogg JP. Tamoxifen-induced regression of breast cysts. Clin Imaging. 1998 Mar-Apr;22(2):95-8. doi: 10.1016/s0899-7071(97)00076-4. PMID 9543585
- BACKGROUNDTan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N. Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst. 2003 Feb 19;95(4):302-7. doi: 10.1093/jnci/95.4.302. PMID 12591986