EORTC 10085 (Male breast cancer) is an intergroup EORTC led project which consists of three parts: 1) a retrospective joint analysis of clinical and centrally reviewed pathological data with the aim of improving our knowledge about the biology of male BC; 2) a prospective international registry and 3) an endocrine therapy clinical trial if deemed feasible.
- The first part of the program completed recruitment in September 2013 and was a great success with 1,822 patients registered. Further details are described in the “Recent Achievements” section.
- The second part started in February 2014 with its first patient registered in May 2014. It is a prospective international registry of all male breast cancer patients treated at the participating institutions for a period of 30 months with collection of clinical data and optional collection of left-over biological material. It will evaluate the number of patients it is feasible to recruit for a future clinical trial; describe patterns of care; and assess sample collection rate. An optional Quality of Life sub study is implemented and will use the EORTC QLQ-30 questionnaire and items from the BR-23 and PR-25 questionnaires.
- The third part, a clinical trial evaluating the role of the androgen receptor enzalutamide, is currently under development. It has been endorsed by the EORTC Board (EORTC 1413) and is expected to start in 2015.
EORTC 1307 / BIG 5-13 (BRAVO) is a registration trial for already pretreated patients with metastatic HER2 negative breast cancer and germline BRCA mutations. The main objective is to compare the effectiveness of an experimental study medication, niraparib (a PARP inhibitor), to standard chemotherapy treatments in patients with breast cancer who are BRCA1 or BRCA2 positive, HER2 negative, and have not responded well to other treatments. A total of 306 patients will be randomized, two thirds of whom will receive treatment with niraparib, while one third will be treated with the physician’s choice. It started in November 2013 and up-to-now 87 patients have been enrolled.
This trial is sponsored by the pharmaceutical company TESARO.
EORTC 90091-10093 (TREAT-CTC) investigates the effect of trastuzumab on the presence of circulating tumor cells (CTCs) in Her2-negative primary breast cancer (BC) patients following treatment completion. Her2-negative primary BC patients who have completed neo- or adjuvant chemotherapy and surgery are tested for CTCs. If CTC positivity has been confirmed, the eligible patients are either randomized to the trastuzumab arm or observation arm. CTC testing is repeated after 18 weeks in both arms. The main objective is to evaluate whether trastuzumab decreases the detection rate of CTC in patients with HER2-negative primary BC by comparing the trastuzumab treated arm to the observation arm. The trial is open since 2013 and is currently active for accrual in of the sites from Austria, Belgium, France, Germany and United Kingdom.
EORTC 10041 / BIG 3-04 (MINDACT) recruited more than 6,600 patients in 111 institutions across nine countries from February 2007 to July 2011. MINDACT is an EORTC sponsored multicenter, prospective, phase III trial whose participants are early stage breast cancer patients who are either node negative or have one to three positive lymph nodes. It compares the 70-gene prognostic signature (Mammaprint), a genomic test developed with micro-array technology, to traditional clinical-pathological methods for assessing the risk of breast cancer recurrence in women with early breast cancer. A feasibility pilot study on the first 800 patients was published in EJC (Eur J Cancer. 2011 Dec;47(18):2742-9). The baseline data have already been presented at ESMO 2013 (Abstract n°2062) and the manuscript is in preparation.
EORTC 1401 / BOOG 2014-04 (LORD) is a phase III non-inferiority trial that will assess the safety of active surveillance in women with low-risk DCIS. The primary objective of this study will be to determine whether low-grade DCIS can safely be managed by an active surveillance strategy or that conventional treatment, being either WLE alone, WLE + RT, or mastectomy, and possibly HT, followed by active surveillance, will remain standard of care. Safety will be measured by ipsilateral invasive breast cancer-free percentage at 10 years. A total of 1,240 low-grade DCIS patients will be randomized and followed-up for 10 years. The study is expected to start in 2015 and will involve a large international collaboration.