Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).

NCT01703520 | Completed

• 2 other identifiers: 0906-1622003.021
• Study Type: observational
• Target: 575,216
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.

Conditions

Male Breast Cancer

Keywords

Males breast cancer; Finasteride; PROSCAR®; PROPECIA®

Outcome Measures

Primary Outcomes (4)

• Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year

  Up to 14 years

• Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride

  Up to 14 years

• Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride

  Up to 14 years

• Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls

  Up to 19 years

Study Arms (4)

Male Finasteride Users

Male finasteride users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).

Male Finasteride Non-users

Country-matched male finasteride non-users aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).

Men with Breast Cancer

Breast cancer cases among men aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).

Men without Breast Cancer

Country- and age-matched controls: men without breast cancer aged 35 years and above in the registries of Denmark (1995-2013), Finland (1994-2013), Norway (2008-2013), and Sweden (2005-2013).

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden

You may qualify if:

• Participant's study medical information available in population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, or Sweden within the observation period of 1995 to 2013
• Male with breast cancer with medical information in one of the 4 country-specific registries in this study OR country- and age-matched control men without breast cancer and with medical information in one of the 4 country-specific registries
• Study participant's exposure to finasteride is available

You may not qualify if:

• For country- and age-matched control men without breast cancer
• Previous cancer diagnosis or treatment for cancer except non-melanoma skin cancer
• Previous prostatectomy
• Finasteride or dutasteride use (dutasteride is a drug in the same class as finasteride) within first 6 months of registration in the prescription registers (new user design).

Sponsors & Collaborators

• Organon and Co: lead
• Institute for Applied Economics and Health Research Aps: collaborator

Related Publications (1)

• Meijer M, Thygesen LC, Green A, Emneus M, Brasso K, Iversen P, Pukkala E, Bolin K, Stavem K, Ersboll AK. Finasteride treatment and male breast cancer: a register-based cohort study in four Nordic countries. Cancer Med. 2018 Jan;7(1):254-260. doi: 10.1002/cam4.1273. Epub 2017 Dec 13.

  PMID: 29239131 RESULT

MeSH Terms

Conditions

Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 10, 2012
• Study Start: May 1, 2011
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: May 10, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share