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International Programme of Breast Cancer in Men (BIG 2-03 / EORTC-10085p-BCG)

Clinical and Biological Characterization of Male Breast Cancer: an International EORTC, BIG, TBCRC and NABCG Intergroup Study


ClinicalTrials.gov identifier: NCT01101425

WHAT

An international and purely academic programme of registration and biologic characterization of male breast cancer. Its objective is to gather and analyze critical medical information about the biology and evolution of male breast cancer.

WHY

Because male breast cancer accounts for less than 1% of all breast cancers diagnosed worldwide, not much has been done in terms of research so far and the disease is still largely unknown.

The programme aims to:

- improve our knowledge of this rare disease

- contribute to guiding doctors towards better treatments for patients with male breast cancer in the future.

WHO

Patients

The prospective part (see below) will recruit all male patients, 18 years old or over, diagnosed with histologically proven invasive breast cancer, independently from of the stage of disease, the initial diagnosis or the treatment received.

WHO

Research Groups

Coordinating groups: European Organization for Research and Treatment of Cancer (EORTC) (sponsor) / North American Breast Cancer Group (NABCG) / Translational Breast Cancer Research Consortium (TBCRC) (US)

Participating BIG Collaborative Groups:

EORTC Breast Cancer Group (Coordinating Group), Borstkanker Onderzoek Groep (BOOG), Hellenic Cooperative Oncology Group (HeCOG), Hellenic Oncology Research Group (HORG), Ireland Cooperative Oncology Research Group (ICORG), Latin American Cooperative Oncology Group (LACOG),  Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung (SAKK), Swedish Association of Breast Oncologists (SABO).

HOW

The “International Programme of Breast Cancer in Men” consists of three parts:

1) a retrospective joint analysis of the clinical and biological data of male breast cancer cases diagnosed from 1990 to 2010 in European and US hospitals participating in the programme. This part required the collection and analysis of a significant number of tumour blocks and clinical data.

2) a prospective international registry with collection of data on incidence, diagnostics, biological characteristics, current treatment strategies, and outcome of all male breast cancer patients treated at the participating institutions for a period of 30 months.

3) a clinical study based on the results of parts 1) and 2) will be set up in the future to test a new treatment for men affected by the disease.

WHEN

• The retrospective analysis (part 1) started in 2010 and was closed in September 2013 with a total of 1822 patients enrolled

• The prospective registry (part 2) started in 2014 and is expected to last about 30 months.

• Discussions are ongoing for the set-up of a clinical trial (part 3) testing a new treatment specifically for men affected by breast cancer

WHERE

16 countries
More than 180 sites

RELATED PUBLICATIONS / PRESENTATIONS

- San Antonio 2014 oral presentation:

Characterization of male breast cancer: First results of the EORTC10085/TBCRC/BIG/NABCG International Male BC Program

- Multidisciplinary meeting on male breast cancer: summary and research recommendations. Korde L A, Zujewski J A, Kamin L, Giordano S, Domchek S, Anderson W F, Bartlett J M S, Gelmon K, Nahleh Z, Bergh J, Cutuli B, Pruneri G, McCaskill-Stevens W, Gralow J, Hortobagyi G and Cardoso F 
J Clin Oncol. 2010 Apr 20;28(12):2114-22. doi: 10.1200/JCO.2009.25.5729. Epub 2010 Mar 22.

- Male breast cancer precursor lesions: analysis of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer ProgramDoebar S C, Slaets L, Cardoso F,  Giordano S H,  Bartlett J M S, Tryfonidis K, Dijkstra N H, Schröder C P, van Asperen C J, Linderholm B, Benstead K, Dinjens W N M, van Marion R,  van Diest P J, Martens J W M and van Deurzen C H M 
Modern Pathology , 13 January 2017, doi:10.1038/modpathol.2016.229 

FUNDING / SUPPORT

Academic study supported by the Breast Cancer Research Foundation (BCRF), the EORTC Breast Cancer Group, the Dutch Pink Ribbon, the EBCC Council, the Swedish Breast Cancer Association (BRO), and the Susan G. Komen For the Cure.



 

To learn more about this study: http://www.eortc.org/clinical-trials/

Read also:
Male and female breast cancers are not identical
Europe and US join their efforts to better understand male breast cancer
Meet Dr. Fatima Cardoso, principal investigator of the International Male Breast Cancer Programme

Last update: July 2015

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