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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01703520

Enrollment

575216

Registered

2012-10-10

Start date

2011-05-01

Completion date

2017-11-30

Last updated

2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Breast Cancer

Keywords

Males breast cancer, Finasteride, PROSCAR®, PROPECIA®

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

35 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
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

Outcome results