Male Breast CancerBR MaleNCT07455110
EORTC Quality of Life Measurement in Males With Breast Cancer
An observational study of Male Breast Cancer and Quality of Life, run by Helios University Hospital Wuppertal at 1 site in Germany.
Trial summary
Around 1% of all new cases of breast cancer (BC) diagnosed annually occur in men. Most research to date has focused on female breast cancer (FBC). So what is known about breast cancer in men has been mostly derived from the research and treatment of FBC. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Breast Cancer, Quality of Life, Breast Cancer
- What is being tested?
- structured Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 31 Mar 2023
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Interviews with patients, who meet the eligibility criteria will be undertaken to get information on the most relevant issues influencing QoL. Also HCP with special knowledge in the field will be interviewed to discuss and consider the potential issues (experts from the EORTC QLG, collaborating centres, EORTC Breast Group, as well as experts from the International Male BC Consortium Group).
Who may be able to join
- Male sex
- Evidence of invasive breast cancer (any type) and/or ductal carcinoma in situ (DCIS) (current or anamnestic).
- Must be able and willing to complete the questionnaires.
- Must be able to understand and speak the language in which the patient will complete the questionnaire.
Who cannot join
- 1. Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios University Clinic Wuppertal, University Witten/Herdecke
Wuppertal, North Rhine-Westphalia, 42283
About this study
Official title: Adaption of the EORTC Quality of Life Breast Cancer Module for Male Breast Cancer - Phase I
Around 1% of all new cases of breast cancer (BC) diagnosed annually occur in men. Most research to date has focused on female breast cancer (FBC). So what is known about breast cancer in men has been mostly derived from the research and treatment of FBC. Comprehensive, prospective data about Quality of life in men treated for BC is lacking. Therefore, a validated worldwide questionnaire for male BC will be developed.
Read the detailed description
One percent of all new cases of breast cancer (BC) diagnosed annually is male BC. Although, the incidence increased by about 26% over the past 25 years, basic and clinical research focusing on male BC is limited. Care of male breast cancer is largely based on extrapolation from treatment strategies and management of symptoms in women. Comprehensive, prospective data about QoL in men treated for BC are lacking. A few studies have focused on symptoms and two small studies have focused on QoL.
The evaluation of the QoL issues relevant for male BC, as well as the translation of issues into items to build the tool for QoL assessment in male BC will be carried through four phases: 1.Literature review: A systematic review with the question what factors are unique to male BC in influencing their QoL and what QoL measures exist for male BC will be done by review of all studies with male BC, investigator brochures (IB) of the describing side effects, review of the existing issues in other EORTC modules . 2. Interviews with patients: Interviews with patients will be undertaken to get information on the most relevant issues influencing QoL. The interviews can be held face-to-face or via telephone. The patient interviews are used to create a list of relevant and important issues which are already covered by the EORTC QLQ-C30, QLQ-BR45 and QLQ-PR25. A semi-structured interview will be carried out. In case of phone interviews, the study documents are handed out in advance so that the patient has the documents available during the interview. Patients will also be asked to rate the importance of each of the items ( 4-point Likert scale) , the appropriateness of the way the items are phrased and about options of alternative wording for items, which a priori are likely to be different for female BC or prostate patients with cancer. Additional issues will be documented carefully. 3.Interviews with health care professionals (HCP): HCP with special knowledge in the field will be interviewed to discuss and consider the potential issues (experts from the EORTC QLG, collaborating centres, EORTC Breast Group, as well as experts from the International Male BC Consortium Group). 4.Consultation of experts in Oncology and QoL: We will seek expert advice from experts in the field of treatment of male BC and in Qol assessment. The study proposes to gather all available evidence from the literature, as well as data from the qualitative interview and develop a succinct summary. Experts will be asked to comment on our findings and will also be asked specific questions around the necessity of the development of a new module, based on those findings and their expert views. These data will be collated and reported in the final report.
The study proposes to carry out an evaluation of the QoL issues relevant for male BC, and translating the issues in the items to build the tool for QoL assessment in male BC. The specific aims are:
- To carry out an evaluation of the EORTC QLQ-BR 45 (adapting for male BC) and for suitability of use in male BC patients
- To carry out an evaluation of the EORTC QLQ-PR25 (adapting for male BC) for suitability of use in male BC patients
- To provide recommendations to the EC on a suitable assessment approach to assess HRQOL in male BC
- Conditions
- Male Breast Cancer, Quality of Life, Breast Cancer
- Being tested
- structured Interview
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured InterviewBehavioural
Interviews with patients and health care professionals(HCP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevance
Mean item relevance score (range 1-4; 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) on a study-specific issue list developed to identify quality of life issues in male breast cancer patients. Participants rate the extent to which they experienced each issue during the specified recall period (past 7 days or past 4 weeks, depending on item specification). Higher scores indicate greater perceived relevance of the issue.
Measured: Single assessment at study enrollment (issues rated with recall period of the past 7 days or past 4 weeks, depending on item specification)
Importance
Percentage of participants selecting each issue for inclusion in a male breast cancer-specific quality of life questionnaire. Participants are instructed to select approximately 25% (±5%) of issues (approximately 11-17 items) that they consider most important for assessing quality of life. Item selection frequency will be used to inform item retention decisions.
Measured: Single assessment at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Nov 2019
- Primary completion20 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios University Hospital Wuppertal
- Sponsor type
- University, hospital or other
- Collaborators
- Mugla Sitki Kocman University School of Medicine, UNED Pamplona, Unidad de cancer, Sorlandet Hospital HF, Medical University Innsbruck, Sunnybrook Health Sciences Centre, East Kent Gynaecological Oncology Centre, Queen Elizabeth the Queen Mother Hospital, Copenhagen University Hospital, Rigshospitalet, University of Southern Denmark, University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Vesna Bjelic-Radisic, Prof, Principal investigator, Helios University Clinic Wuppertal, University Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455110
- Sponsor's protocol ID
- 002-2019
- Acronym
- BR Male
- Status last verified
- Mar 2026
- First submitted
- 14 Jul 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaption of the EORTC Quality of Life Breast Cancer Module for Male Breast Cancer - Phase I
- ClinicalTrials.gov ID
- NCT07455110
- Acronym / sponsor ID
- BR Male / 002-2019
- Conditions
- Male Breast Cancer, Quality of Life, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Helios University Hospital WuppertalUniversity, hospital or other
- Collaborators
- Mugla Sitki Kocman University School of Medicine, UNED Pamplona, Unidad de cancer, Sorlandet Hospital HF, Medical University Innsbruck, Sunnybrook Health Sciences Centre, East Kent Gynaecological Oncology Centre, Queen Elizabeth the Queen Mother Hospital, Copenhagen University Hospital, Rigshospitalet, University of Southern Denmark, University of Roma La Sapienza
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 6 Mar 2026 (actual)
- 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.
Around 1% of all new cases of breast cancer (BC) diagnosed annually occur in men. Most research to date has focused on female breast cancer (FBC). So what is known about breast cancer in men has been mostly derived from the research and treatment of FBC. Comprehensive, prospective data about Quality of life in men treated for BC is lacking. Therefore, a validated worldwide questionnaire for male BC will be developed.
Detailed description
One percent of all new cases of breast cancer (BC) diagnosed annually is male BC. Although, the incidence increased by about 26% over the past 25 years, basic and clinical research focusing on male BC is limited. Care of male breast cancer is largely based on extrapolation from treatment strategies and management of symptoms in women. Comprehensive, prospective data about QoL in men treated for BC are lacking. A few studies have focused on symptoms and two small studies have focused on QoL.
The evaluation of the QoL issues relevant for male BC, as well as the translation of issues into items to build the tool for QoL assessment in male BC will be carried through four phases: 1.Literature review: A systematic review with the question what factors are unique to male BC in influencing their QoL and what QoL measures exist for male BC will be done by review of all studies with male BC, investigator brochures (IB) of the describing side effects, review of the existing issues in other EORTC modules . 2. Interviews with patients: Interviews with patients will be undertaken to get information on the most relevant issues influencing QoL. The interviews can be held face-to-face or via telephone. The patient interviews are used to create a list of relevant and important issues which are already covered by the EORTC QLQ-C30, QLQ-BR45 and QLQ-PR25. A semi-structured interview will be carried out. In case of phone interviews, the study documents are handed out in advance so that the patient has the documents available during the interview. Patients will also be asked to rate the importance of each of the items ( 4-point Likert scale) , the appropriateness of the way the items are phrased and about options of alternative wording for items, which a priori are likely to be different for female BC or prostate patients with cancer. Additional issues will be documented carefully. 3.Interviews with health care professionals (HCP): HCP with special knowledge in the field will be interviewed to discuss and consider the potential issues (experts from the EORTC QLG, collaborating centres, EORTC Breast Group, as well as experts from the International Male BC Consortium Group). 4.Consultation of experts in Oncology and QoL: We will seek expert advice from experts in the field of treatment of male BC and in Qol assessment. The study proposes to gather all available evidence from the literature, as well as data from the qualitative interview and develop a succinct summary. Experts will be asked to comment on our findings and will also be asked specific questions around the necessity of the development of a new module, based on those findings and their expert views. These data will be collated and reported in the final report.
The study proposes to carry out an evaluation of the QoL issues relevant for male BC, and translating the issues in the items to build the tool for QoL assessment in male BC. The specific aims are:
- To carry out an evaluation of the EORTC QLQ-BR 45 (adapting for male BC) and for suitability of use in male BC patients
- To carry out an evaluation of the EORTC QLQ-PR25 (adapting for male BC) for suitability of use in male BC patients
- To provide recommendations to the EC on a suitable assessment approach to assess HRQOL in male BC
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Interviews with patients, who meet the eligibility criteria will be undertaken to get information on the most relevant issues influencing QoL. Also HCP with special knowledge in the field will be interviewed to discuss and consider the potential issues (experts from the EORTC QLG, collaborating centres, EORTC Breast Group, as well as experts from the International Male BC Consortium Group).
Key inclusion criteria (4 listed)
- Male sex
- Evidence of invasive breast cancer (any type) and/or ductal carcinoma in situ (DCIS) (current or anamnestic).
- Must be able and willing to complete the questionnaires.
- Must be able to understand and speak the language in which the patient will complete the questionnaire.
Key exclusion criteria (1 listed)
- 1. Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| structured InterviewInterviews with patients and health care professionals(HCP) | Behavioural | – |
Primary outcome
Relevance
Time frame: Single assessment at study enrollment (issues rated with recall period of the past 7 days or past 4 weeks, depending on item specification)
Mean item relevance score (range 1-4; 1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) on a study-specific issue list developed to identify quality of life issues in male breast cancer patients. Participants rate the extent to which they experienced each issue during the specified recall period (past 7 days or past 4 weeks, depending on item specification). Higher scores indicate greater perceived relevance of the issue.
Importance
Time frame: Single assessment at study enrollment
Percentage of participants selecting each issue for inclusion in a male breast cancer-specific quality of life questionnaire. Participants are instructed to select approximately 25% (±5%) of issues (approximately 11-17 items) that they consider most important for assessing quality of life. Item selection frequency will be used to inform item retention decisions.
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Vesna Bjelic-Radisic, Prof principal investigator
Helios University Clinic Wuppertal, University Witten/Herdecke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Breast Cancer and Quality of Life, run by Helios University Hospital Wuppertal at 1 site in Germany.
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 4 inclusion and 1 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Relevance (time frame: Single assessment at study enrollment (issues rated with recall period of the past 7 days or past 4 weeks, depending on item specification)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.