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

Overview

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.

Full Title of Study: “Finasteride and Male Breast Cancer – A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 30, 2017

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Stage 1 – Person-Years of Exposure to Finasteride by Participant Age and Year
    • Time Frame: Up to 14 years
  • Stage 1 – Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride
    • Time Frame: Up to 14 years
  • Stage 1 – All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride
    • Time Frame: Up to 14 years
  • Stage 2 – Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls
    • Time Frame: Up to 19 years

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

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).

Gender Eligibility: Male

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Collaborator
    • Institute for Applied Economics and Health Research Aps
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

Meijer M, Thygesen LC, Green A, Emneus M, Brasso K, Iversen P, Pukkala E, Bolin K, Stavem K, Ersbøll 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.

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