International Programme of Breast Cancer in Men (BIG 2-07 / EORTC-10085p-BCG)

Intro text: 

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

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.

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.

Results from the retrospective collection and analysis of clinical data and biological samples from 1,822 patients were published in the Annals of Oncology on 1 February 2018.

The findings confirmed that male breast cancer is indeed different to female breast cancer in terms of histology and grading. Thanks to RNA sequencing on 152 tumour samples, five intrinsic subtypes of male breast cancer with various gene expression profiles were identified. These results also support the results reported by I. Johansson et al. that suggest that there is a subtype of the disease that occurs exclusively in men.

Furthermore, the results also indicated that, although over 90% of male patients were diagnosed with ER+ breast cancer, only 77% received adjuvant endocrine therapy, which is the prescribed treatment for this type of breast cancer.

What’s more, the prospective registry of newly diagnosed patients, which was built within the period of 30 months and concluded in February 2017, proved the feasibility of a therapeutic clinical trial that could generate meaningful results in a rare disease setting, having recruited 550 male breast cancer 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.

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).

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.

• 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 lasted 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

  • 16 countries
  • More than 180 sites

- San Antonio 2014 oral presentation: Characterization of male breast cancer: First results of the EORTC10085/TBCRC/BIG/NABCG International Male BC Program 

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. identifier: NCT01101425


To learn more about this study visit the EORTC website

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