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

NCT00999921 | Completed Phase 4 Results DMC

• 1 other identifier: MSVP-107/08
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Fibrocystic Breast Disease; Fibroadenoma; Mastalgia

Outcome Measures

Primary Outcomes (2)

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

  Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.

  3 months

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

  All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response

  3 months

Secondary Outcomes (1)

• Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)

  3 months

Study Arms (2)

Tamoxifen

EXPERIMENTAL

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

Drug: Tamoxifen

Evening Primrose Oil

EXPERIMENTAL

1000 mg daily for 3 months

Drug: Evening Primrose Oil

Interventions

Tamoxifen DRUG

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

Tamoxifen

Evening Primrose Oil DRUG

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

Evening Primrose Oil

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
• Benign Breast disease amenable to hormonal therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College and Hospital Kolkata: lead

Study Sites (1)

Department of Surgery, Medical College, Kolkata

Kolkata, West Bengal, 700073, India

Location

Related Publications (4)

• 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.

  PMID: 17509880 BACKGROUND

• 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.

  PMID: 455247 BACKGROUND

• 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.

  PMID: 9543585 BACKGROUND

• 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.

  PMID: 12591986 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Fibrocystic Breast Disease; Fibroadenoma; Mastodynia

Interventions

Tamoxifen; evening primrose oil

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Md Tanveer Adil
• Organization: Medical College and Hospital Kolkata

tanveer.cmc@gmail.com

0091-9830154566

Study Officials

• Md Tanveer Adil

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

  PRINCIPAL INVESTIGATOR

• Rumana Rahman

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

  STUDY DIRECTOR

• Soumen Das

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

  STUDY DIRECTOR

• Sudip Sarkar

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

  STUDY DIRECTOR

• Rupesh Kumar

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

  STUDY DIRECTOR

• Utpal De

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: January 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 18, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-04

Locations

IN (1)