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

NCT ID: NCT00999921

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Benign Breast Disease; Fibrocystic Disease of Breast; Fibroadenoma; Mastalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tamoxifen

10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.

Evening Primrose Oil

1000 mg daily for 3 months

Group Type: EXPERIMENTAL

Evening Primrose Oil

Intervention Type: DRUG

Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Interventions

Tamoxifen

Tamoxifen is given at 10 mg once daily between Day 5 and Day 25 of menstrual cycle for 3 cycles.

Intervention Type: DRUG

Evening Primrose Oil

Evening Primrose Oil is given at 1000 mg two times daily for 3 months.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College and Hospital Kolkata

OTHER

Sponsor Role: lead

Responsible Party

Md Tanveer Adil

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Md Tanveer Adil

Role: PRINCIPAL_INVESTIGATOR

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Rumana Rahman

Role: STUDY_DIRECTOR

Resident, Department of Gynaecology and Obstetrics, Medical College and Hospital, Kolkata

Soumen Das

Role: STUDY_DIRECTOR

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Sudip Sarkar

Role: STUDY_DIRECTOR

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Rupesh Kumar

Role: STUDY_DIRECTOR

Resident, Department of Surgery, Medical College and Hospital, Kolkata

Utpal De

Role: STUDY_CHAIR

Professor, Department of Surgery, Medical College and Hospital, Kolkata

Locations

Department of Surgery, Medical College, Kolkata

Kolkata, West Bengal, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 17509880 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 455247 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9543585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12591986 (View on PubMed)

Other Identifiers

MSVP-107/08

Identifier Type: -

Identifier Source: org_study_id