Overview

This trial is active, not recruiting.

Condition male breast cancer
Phase phase 4
Sponsor Merck Sharp & Dohme Corp.
Collaborator Institute for Applied Economics and Health Research Aps
Start date May 2011
End date June 2017
Trial size 428000 participants
Trial identifier NCT01703520, 0906-162, 2003.021

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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).
Country- and age-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).
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).
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).

Primary Outcomes

Measure
Person-Years of Exposure to Finasteride by Participant Age and Year
time frame: Up to 14 years
Incidence Rates of Male Breast Cancer by Exposure to Finasteride
time frame: Up to 14 years
All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride
time frame: Up to 14 years

Eligibility Criteria

Male participants at least 35 years old.

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).

Additional Information

Official title Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..