Vall d´Hebron, VHIO and SOLTI Head Up an International ´Dream Team´ against Breast Cancer

• The team will be coordinating a study that aims to investigate whether the BKM120 drug can be regarded as an effective treatment against triple-negative breast cancer.
• The study is supported by Stand Up to Cancer (SU2C), a non-profit organization whose objectives include promoting translational cancer research.

Barcelona, 19 September 2012. The Vall d’Hebron Breast Cancer Unit, the Vall d’Hebron Institute of Oncology (VHIO) and SOLTI, an academic breast cancer research group , are heading up a multi-centre international study involving four Spanish and three North American research centres*. The aim of the study is to investigate whether BKM120, a drug that inhibits the PI3K pathway (phosphatidylinositol-3-Kinase) can be an effective treatment against triple-negative breast cancer.

At present it is known that breast cancer can be classified into different subtypes with varying prognoses and responses to treatment. This classification is essentially based on the presence of hormone receptors (oestrogen and progesterone) and the HER2 receptor. In clinical practice this has led to the development of increasingly selective and optimal treatments for patients. Advances in breast cancer treatment using new drugs on accurately-selected populations, along with the implementation of public screening programs, have contributed in recent years to reducing mortality from this disease.

Triple-negative breast cancer: the most aggressive form

Triple-negative breast cancer is defined by the absence of hormone receptors and HER2. This type of breast cancer is an aggressive variety of the disease that generally appears in younger women. Few treatment options beyond chemotherapy and anti-angiogenic agents are currently available. The present study aims to test whether BKM120 is effective for these patients and also, by means of biomarkers in the blood or in the tumour, identify which tumours respond to this new treatment.

The design initiative for this study falls within the grant awarded by the organization Stand Up to Cancer (SU2C), a non-profit entity whose objectives include supporting translational cancer research to ensure that the benefits of the most innovative treatments resulting from basic research can rapidly reach patients through study designs that allow fast-track application of the results.

“Dream Teams” against cancer

SU2C promotes the formation of multidisciplinary teams, known as “Dream Teams”, which bring together the talent and knowledge of top scientists and cancer specialists from all over the world, bringing added value to research and allowing the rapid transfer of findings from basic research to clinical application.

Each Dream Team is made up of leading experts in certain tumour types and receives funding to develop their respective project over a three-year period in a highly collaborative and independent environment. The removal of bureaucratic barriers prevents part of the funding being lost through intermediaries, allowing experts to concentrate exhaustively on their research. This structure has been designed to obtain the optimum results with the highest assurance in the shortest possible time.

The team of Dr José Baselga from the VHIO is one of the Dream Teams selected by SU2C to take part in this ambitious project and head up the study on BKM 120 for the treatment of triple-negative breast cancer. This top-level collaboration stems from the experience and knowledge of the groups of excellence in the Breast Cancer Unit and the Research Unit for the Molecular Therapy of Cancer – “la Caixa” at the VHIO, headed respectively by Dr Javier Cortés and Dr Jordi Rodón, as well as the expertise of SOLTI in coordinating multi-centre academic studies.

The Research Unit for the Molecular Therapy of Cancer (UITM) “la Caixa” and the Breast Cancer Unit already boast four years’ experience in researching a broad spectrum of PI3K pathway inhibitors. They recently presented a study at the Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, June 1 – 5, 2012, on the actions of these drugs in patients suffering from breast cancer, in monotherapy or in combination with other treatments. “This study, with data from the largest patient sample ever used, presents some encouraging findings with regard to the control time of the disease in metastatic patients,” explains Dr Cristina Saura, the study coordinator in Spain as a member of SOLTI.

Innovations in breast cancer treatment

The PI3K pathway regulates key cellular functions such as cell growth, proliferation and survival. The appearance of mutations in this pathway is common and seems to contribute to the development of certain types of cancer in women, such as cancers of the breast, ovaries, uterus and endometrium. These mutations have also been implicated in the resistance mechanisms to certain conventional treatments (chemotherapy, hormone treatment or Trastuzumab).

The study that is already underway and open at the Vall d’Hebron University Hospital is a Phase II trial with a specific PI3K pathway inhibitor – the molecule BKM120 – and “the trial aims to determine the clinical activity of the molecule in patients with triple-negative metastatic breast cancer at an advanced stage of the disease still progressing following treatment with chemotherapy,” comments Dr Javier Cortés, the Head of the Breast Cancer Unit, and continues, “we are thus talking about advanced disease treatment, when the tumour has progressed to standard treatment options”.

One of the novel aspects of this project is that it has been specifically designed to determine, by an analysis of the genetic profiles of patients, whether there is an identifiable subgroup of patients that particularly responds to this treatment. “The analysis of the genetic profiles of patients who respond and those who don’t will help us to understand the reasons for this response, thanks to the technology and specialist knowledge that only this Dream Team possesses, which gives it a unique value,” explains Dr Rodón, Head of the UITM and principal researcher of this international study.

The study with BKM120 is an example of how the highest level of technology combined with excellence in biomedical research can translate into major benefits for patients. Future lines of research will be directed at the exploration and validation of new predictive biomarkers, bringing us one step closer to realising the promise of personalized medicine. It is becoming increasingly necessary to search for biomarkers of response to these molecules in order to determine, prior to treatment, which patients are going to benefit from this treatment and why.

*The Spanish centers involved in the BKM120 trial are: the University Hospital of Vall d’Hebron in Barcelona, the Valencian Institute of Oncology at the University Hospital of Valencia, and the 12 de Octubre Hospital in Madrid. Three North American centers are also expected to participate: the Dana-Farber Cancer Institute, the Beth Israel Deaconess Medical Centre, and the Dana-Farber Clinic at Faulkner Hospital, all in Boston, MA.

For further information please contact: Amanda Wren, Communications Manager, VHIO, Email: awren@vhio.net, Tel: +34 695207886.

***

About the AACR:

Founded in 1907, the American Association for Cancer Research (AACR) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR’s membership includes 34,000 laboratory, translational and clinical researchers; population scientists; other health care professionals; and cancer advocates residing in more than 90 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis and treatment of cancer by annually convening more than 20 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 18,000 attendees. In addition, the AACR publishes seven peer-reviewed scientific journals and a magazine for cancer survivors, patients and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration and scientific oversight of individual and team science grants in cancer research that have the potential for patient benefit. The AACR actively communicates with legislators and policy makers about the value of cancer research and related biomedical science in saving lives from cancer.

For more information about the AACR, visit www.aacr.org

About Stand Up To Cancer

Stand Up To Cancer (SU2C) – a program of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization – raises funds to accelerate the pace of groundbreaking translational research that will get new therapies to patients quickly.

SU2C’s “Dream Team” approach to funding translational cancer research enables scientists from different disciplines at research centers across the country and internationally to collaborate on projects geared toward getting new, less toxic treatments to patients as quickly as possible. Monies also support innovative cancer research projects that are often deemed “too risky” by conventional funding sources. Currently, more than 200 scientists from over 60 institutions are involved in SU2C-funded research projects – either as members of Dream Teams or as recipients of Innovative Research Grants. As SU2C’s scientific collaborator, the American Association for Cancer Research, led by a prestigious SU2C Scientific Advisory Committee, provides scientific oversight, expert review of the research projects and grants administration.

Members of the SU2C Executive Leadership Council include Katie Couric; the Entertainment Industry Foundation, represented by Board of Directors Chairperson Sherry Lansing (Founder of the Sherry Lansing Foundation), CEO Lisa Paulsen and Senior Vice President Kathleen Lobb; Rusty Robertson and Sue Schwartz of the Robertson Schwartz Agency; Pam Williams, partner at Laura Ziskin Productions; and nonprofit executive Ellen Ziffren. The late Laura Ziskin, a legendary film producer who executive produced the 2008 and 2010 SU2C telecasts, was also a co-founder of Stand Up To Cancer.

For more information about the SU2C, visit http://standup2cancer.org

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