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

Completed

• Conditions: Male Breast Cancer

• Registration Number: NCT01703520
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-01
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-10
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 575216

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year	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
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