Clinical trial NCT00999921: Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Breast Disease
Fibrocystic Disease of Breast
Fibroadenoma
Mastalgia
Keywords: Fibrocystic Breast Disease
Fibroadenoma
Mastalgia
Lead sponsor: Medical College and Hospital Kolkata
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 256
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)
timeFrame: 3 months
measure: Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)
timeFrame: 3 months
Other outcomes:
Locations:
city: Kolkata
country: India
facility: Department of Surgery, Medical College, Kolkata
state: West Bengal
Study officials:
affiliation: Resident, Department of Surgery, Medical College and Hospital, Kolkata
name: Md Tanveer Adil
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata
name: Rumana Rahman
role: STUDY_DIRECTOR
affiliation: Resident, Department of Surgery, Medical College and Hospital, Kolkata
name: Soumen Das
role: STUDY_DIRECTOR
affiliation: Resident, Department of Surgery, Medical College and Hospital, Kolkata
name: Sudip Sarkar
role: STUDY_DIRECTOR
affiliation: Resident, Department of Surgery, Medical College and Hospital, Kolkata
name: Rupesh Kumar
role: STUDY_DIRECTOR
affiliation: Professor, Department of Surgery, Medical College and Hospital, Kolkata
name: Utpal De
role: STUDY_CHAIR
References:
citation: Srivastava 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.
citation: Allegra 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.
citation: Hurst 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.
citation: Tan-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.