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

Organon

Status: Completed

Conditions: Male Breast Cancer

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01703520

2003.021 (Other Identifier)

0906-162

Details and patient eligibility

About

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.

Enrollment: 575,216 patients

Sex: Male

Ages: 35+ years old

Volunteers: No 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).

Trial design

575,216 participants in 4 patient groups

Male Finasteride Users

Description:

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

Description:

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

Description:

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

Description:

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).