Male Breast CancerNCT01703520
Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).
An observational study of Male Breast Cancer, run by Organon and Co.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Male Breast Cancer
- How many people
- 575,216 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2011to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
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.
- Conditions
- Male Breast Cancer
- Keywords
- Males breast cancer, Finasteride, PROSCAR®, PROPECIA®
- Medical subject headings
- Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male Finasteride Users | 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 | 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 | 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 | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year
Measured: Up to 14 years
Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride
Measured: Up to 14 years
Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride
Measured: Up to 14 years
Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls
Measured: Up to 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start1 May 2011
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 575,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Applied Economics and Health Research Aps
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703520
- Sponsor's protocol ID
- 0906-162
- Other IDs
- 2003.021
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2012
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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/cam4.1273. Epub 2017 Dec 13.
PubMed 29239131
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finasteride and Male Breast Cancer - A Register-Based Nested Case-Control Study in Denmark, Finland, Norway, and Sweden
- ClinicalTrials.gov ID
- NCT01703520
- Acronym / sponsor ID
- 0906-162
- Conditions
- Male Breast Cancer
- Keywords
- Males breast cancer, Finasteride, PROSCAR®, PROPECIA®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575,216 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Applied Economics and Health Research Aps
- Study start
- 1 May 2011 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Male Finasteride Users | – | –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 | – | –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 | – | –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 | – | –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). |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population-based health and medical registries, prescription registries, and mortality registries in Denmark, Finland, Norway, and Sweden
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year
Time frame: Up to 14 years
Stage 1 - Initial Incidence Rates of Male Breast Cancer Stratified by Exposure to Finasteride
Time frame: Up to 14 years
Stage 1 - All-Cause Mortality Rates in Males with Breast Cancer by Exposure to Finasteride
Time frame: Up to 14 years
Stage 2 - Odds (or Likelihood) of Exposure to Finasteride in Male Breast Cancer Cases Relative to Controls
Time frame: Up to 19 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 29239131Meijer 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/cam4.1273. Epub 2017 Dec 13.
- Individual participant dataSharing planned: No
Related trials for Male Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Male Breast Cancer, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 - Person-Years of Exposure to Finasteride by Participant Age and Year (time frame: Up to 14 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01703520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.