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

Male Breast Cancer Clinical Trial

Official title:

Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703520
• Other study ID #: 0906-162
• Secondary ID: 2003.021
• Status: Completed
• Start date: May 1, 2011
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575216
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Institute for Applied Economics and Health Research Aps

References & 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year		Up to 14 years
Primary	Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride		Up to 14 years
Primary	Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride		Up to 14 years
Primary	Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls		Up to 19 years