Clinical trial · Observational
Male Breast Cancer: Understanding the Biology for Improved Patient Care
Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary.
- timeFrame
- end of study
- measure
- Patient and disease characteristics.
- timeFrame
- end of study
- measure
- Patterns of treatment offered to these patients
- timeFrame
- end of study
- measure
- Biological characterization of the disease
- timeFrame
- End of study
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 protective 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.
References
Publications (0)
Data not yet available