Male Breast Cancer: Understanding the Biology for Improved Patient Care
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-003493
NCT ID: NCT01101425
Sponsor Protocol Number: TBCRC029
About this study
Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.
Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010.
Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Retrospective part (closed to patients registration):
- Men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.
- A FFPE tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory
Prospective part:
- All men, with histologically proven invasive breast cancer, newly presenting at the center irrespective of the stage of disease, initial diagnosis date or treatment received
- patients cannot be registered in both the retrospective and prospective parts of the study
- patients who newly present at the center in the 3 months prior to center activation are still eligible as long as they were not previously included in the retrospective part of the study
- Before patient registration, written informed consent must be obtained according to ICH/GCP, and national/local regulations.
- Collection of left-over FFPE and frozen tumor samples as well as blood is optional.
Both parts:
- Concomitant DCIS or LCIS are allowed only if invasive cancer is present.
- Patients should be 18 years or over at the time of diagnosis.
- The study will accept all stages of disease (e.g. early BC, locally advanced and metastatic disease) independent of the treatment received.
- Patients with past or concurrent other malignancies are eligible.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Kathryn Ruddy, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available