Male Breast Cancer: Understanding the Biology for Improved Patient Care
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Objectives retrospective part (closed to patients registration in September 2013):
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To perform a large international joint retrospective analysis of clinical and biological data of male breast cancer (BC) patients treated from 1990 to 2010.
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To create a database of patient characteristics, disease features, treatments received, and clinical outcomes of a large series of men diagnosed with BC from 1990 to 2010 in centers in Europe and USA.
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To perform a central pathological review of the corresponding large series of male BC tumors to determine their biologic characteristics and identify relevant prognostic and predictive markers.
Objectives prospective part (opened early 2014):
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To run a prospective registry of all male BC patients (including newly diagnosed) irrespective of the stage and treatment, in the participating institutions for a period of 30 months; collection of FFPE, fresh frozen and blood samples is optional but highly encouraged.
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Quality of Life sub-study
The two parts of this study will provide important information regarding male BC biology and clinical evolution. The collected follow-up information will provide an overview of the current practice in the early and the advanced disease and also offer precious information of the disease evolution in such rare patients' population.
Study Design
Outcome Measures
Primary Outcome Measures
- Clinical outcomes: survival, progression free survival, time to locoregional relapse, time to distant relapse, time to second primary. [end of study]
- Patient and disease characteristics. [end of study]
- Patterns of treatment offered to these patients [end of study]
- Biological characterization of the disease [End of study]
Eligibility Criteria
Criteria
Retrospective part (closed to patients registration):
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Men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.
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A FFPE tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory
Prospective part:
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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.
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patients cannot be registered in both the retrospective and protective parts of the study
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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
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Before patient registration, written informed consent must be obtained according to ICH/GCP, and national/local regulations.
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Collection of left-over FFPE and frozen tumor samples as well as blood is optional.
Both parts:
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Concomitant DCIS or LCIS are allowed only if invasive cancer is present.
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Patients should be 18 years or over at the time of diagnosis.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University Of Alabama Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
2 | University Of Alabama Comprehensive Cancer Cente | Birmingham | Alabama | United States | 35294 |
3 | UCSF University of California San Francisco Medical Center-Mount Zion | San Francisco | California | United States | 94115 |
4 | Georgetown Lombardi Comprehensive Cancer Center | Washington | District of Columbia | United States | 20007 |
5 | University of Chicago Medicine | Chicago | Illinois | United States | 60637-1470 |
6 | Indiana University Medical Center | Indianapolis | Indiana | United States | 46202-5264 |
7 | Johns Hopkins University CRB1 | Baltimore | Maryland | United States | 21287 |
8 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
9 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115-5450 |
10 | University of Michigan | Ann Arbor | Michigan | United States | 48109-5912 |
11 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
12 | Memorial Sloan-Kettering Cancer Center - Memorial hospital | New York | New York | United States | 10065 |
13 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
14 | Baylor college of Medicine | Houston | Texas | United States | 77030 |
15 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
16 | Baylor College - Ucop | Houston | Texas | United States | |
17 | Fred Hutchison Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109-1023 |
18 | ZNA Middelheim | Antwerpen | Belgium | ||
19 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
20 | CHU St Pierre | Brussels | Belgium | ||
21 | Cliniques Universitaires St. Luc | Brussels | Belgium | ||
22 | Hopital Universitaire Brugmann | Brussels | Belgium | ||
23 | Institut Jules Bordet | Brussels | Belgium | ||
24 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | ||
25 | Hopital De Jolimont | Haine St Paul | Belgium | ||
26 | UZ Leuven | Leuven | Belgium | ||
27 | ZNA Jan Palfijn | Merksem | Belgium | ||
28 | CHU Ucl Namu - Clinique Sainte Elisabeth | Namur | Belgium | ||
29 | AZ Damiaan - Campus Sint-Jozef | Oostende | Belgium | ||
30 | Centro Regional Integrado de Oncologia | Fortaleza | Brazil | 60366-045 | |
31 | Centro de Pesquisas Clinicas em Oncologia | Porto Alegre | Brazil | 90610 000 | |
32 | Ain Shams University Hospital | Cairo | Egypt | ||
33 | Alexandra Hospital | Athens | Greece | ||
34 | Aretaieio Hospital | Athens | Greece | ||
35 | General Hospital of Air Force | Athens | Greece | ||
36 | Hippokration General Hospital Of Athens | Athens | Greece | ||
37 | Hygeia Hospital | Athens | Greece | ||
38 | IASO general hospital | Athens | Greece | ||
39 | University General Hospital Heraklion | Heraklion | Greece | ||
40 | Agioi Anargiroi Hospital | Kifisiá | Greece | ||
41 | General University Hospital Papageorgiou | Thessaloniki | Greece | ||
42 | Thermi Clinic | Thessaloniki | Greece | ||
43 | Cork University Hospital | Cork | Ireland | ||
44 | Beaumont Hospital | Dublin | Ireland | ||
45 | Mater Misericordia Hospital | Dublin | Ireland | ||
46 | St. James'S Hospital | Dublin | Ireland | ||
47 | St. Vincent'S Hospital | Dublin | Ireland | ||
48 | Waterford Regional Hospital | Waterford | Ireland | ||
49 | Instituto Nacional De Cancerologia | Mexico | Mexico | ||
50 | BOOG | Amsterdam | Netherlands | ||
51 | Instituto De Enfermedades Neoplasicas | Lima | Peru | ||
52 | Medical University Of Gdansk | Gdansk | Poland | ||
53 | Maria Sklodowska-Curie Memorial Cancer Centre | Warsaw | Poland | ||
54 | Champalimaud Cancer Center | Lisbon | Portugal | ||
55 | Instituto Portugues De Oncologia - Centro Do Porto | Porto | Portugal | ||
56 | Institute of Oncology and Radiology | Belgrade | Serbia | 11000 | |
57 | Hospital General Vall D'Hebron | Barcelona | Spain | ||
58 | Hospital Universitario 12 De Octubre | Madrid | Spain | ||
59 | Swedish Association of Breast Oncologists | Göteborg | Sweden | ||
60 | Kantonsspital Baden | Baden | Switzerland | ||
61 | Universitaetsspital Basel | Basel | Switzerland | ||
62 | Inselspital | Bern | Switzerland | ||
63 | Sonnenhofklinik Engeriedspital | Bern | Switzerland | ||
64 | Spitalzentrum Biel | Biel | Switzerland | ||
65 | Kantonales Spital Herisau | Herisau | Switzerland | ||
66 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | ||
67 | Cantonal Hospital Liestal | Liestal | Switzerland | ||
68 | Luzerner Kantonsspital | Luzern | Switzerland | ||
69 | Ospedale Beata Vergine | Mendrisio | Switzerland | ||
70 | Hopital de Sion | Sion | Switzerland | ||
71 | Kantonsspital St Gallen | St Gallen | Switzerland | ||
72 | ZeTuP St.Gallen | St Gallen | Switzerland | ||
73 | Radio-Onkologie Berner Oberland AG | Thun | Switzerland | ||
74 | Kantonsspital Winterthur | Winterthur | Switzerland | ||
75 | UniversitaetsSpital Zurich | Zurich | Switzerland | ||
76 | Worthing Hospital | Worthing | West Sussex | United Kingdom | |
77 | City Hospital | Birmingham | United Kingdom | ||
78 | Royal Sussex County Hospital | Brighton | United Kingdom | ||
79 | LLandough Hospital | Cardiff | United Kingdom | ||
80 | Cheltenham General Hospital | Cheltenham | United Kingdom | ||
81 | Leighton Hospital | Crewe | United Kingdom | ||
82 | Queen Margaret Hospital | Dunfermline | United Kingdom | ||
83 | Eastbourne District General Hospital | Eastbourne | United Kingdom | ||
84 | Western General Hospital | Edinburgh | United Kingdom | ||
85 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | ||
86 | New Victoria Hospital | Glasgow | United Kingdom | ||
87 | Crosshouse Hospital | Kilmarnock | United Kingdom | ||
88 | Forth Valley Royal Hospital | Larbert | United Kingdom | ||
89 | Royal Liverpool University Hospital | Liverpool | United Kingdom | ||
90 | Royal Alexandra Hospital | Paisley | United Kingdom | ||
91 | University Hospital of North Tees | Stockton on Tees | United Kingdom | ||
92 | The Great Western Hospital | Swindon | United Kingdom | ||
93 | Wishaw General Hospital | Wishaw | United Kingdom |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Breast International Group
- Swiss Group for Clinical Cancer Research
- Cancer Trials Ireland
- Borstkanker Onderzoek Groep
- Swedish Association of Breast Oncologists
- Hellenic Cooperative Oncology Group
- Hellenic Oncology Research Group
- Latin American Cooperative Oncology Group
- Translational Breast Cancer Research Consortium
Investigators
- Study Chair: Fatima Cardoso, MD, Champalimaud Cancer Center (Portugal)
- Study Chair: Sharon H. Giordano, MD, MPH, M. D. Anderson Cancer Center (TX, USA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EORTC-10085
- BIG 2-07
- TBCRC 029