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Triple-negative breast cancer: trial to develop personalised therapy
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A new trial, teaming researchers in Indiana University with Paradigm, a non-profit genomic sequencing and molecular information company, aims to use advanced genomic sequencing technology to tailor personalised therapies to women with intractable triple-negative breast cancer. In a move away from the ‘one-size-fits-all’ model of cancer therapy towards the emerging personalised medicine options, the research team will use next-generation sequencing techniques on DNA from tumours in women who have not responded to standard chemotherapy. In this way, they hope to identify mutations or changes in expression in genes specific to an individual patient’s tumour and then try to identify a drug that might be expected to target that particular tumour.

Triple-negative breast cancer has a particularly poor prognosis as it is associated with high incidence of recurrence and metastasis to sites such as the brain and lung. Treatment is complicated by the fact that it lacks oestrogen receptor, progesterone receptor and the HER2 protein, all of which are targets for therapy in other forms of breast cancer. This lack of effective therapies for triple-negative breast cancer makes identification of underlying mechanisms and tailored therapies all the more important. The proposed new trial is aimed at testing whether particular tailored treatments can improve survival rates.

In the trial, 130 women who have received chemotherapy and surgery without the hoped-for outcomes, and who are at high risk of recurrence, will be enrolled. Half of these women will be assigned to the standard of care, while the other half will receive genomic sequencing-directed therapy. Michigan University researchers will enrol the participants and collaborate with Paradigm in analysis of the DNA and RNA of tumours remaining after standard chemotherapy. After discussion of each individual patient’s results, each woman will be assigned a drug selected to be specific to her particular form of triple negative breast cancer.

Paradigm CEO Dr Robert Penny further explains the significance of the trial: "This trial is one of only a handful in the world that tests, through a controlled scientific study, whether the use of next-generation sequencing (NGS) to identify specific disease drivers -- and the selection of treatments for women based on those genetic markers -- actually improves survival rates for women…Our ability to interrogate the patient's tumour for DNA mutations, DNA copy number variations, chromosomal changes and mRNA gene expression with next-generation sequencing with clinical quality results is a real differentiator in helping to improve patient care.” Meanwhile, Dr Bryan Schneider of Indiana University explains how the sequencing information could lead to identification of the most individually effective drug: "If the mutation is taking place in a certain gene or protein that controls a certain function, and if the mutation has caused damage in that pathway, one can intuitively pick a drug that may also be interacting in that very same pathway to either try to stop or shut down an overly activated pathway."

While the current trial will focus on triple-negative breast cancer, the research team envisage a time when other cancers can be similarly targeted. Dr Schneider concludes: "We envision a day when we can predict a handful of drugs that will best treat the tumour, derived from the tumour’s unique acquired genetic variability, and then further counsel the patient on which of these might be least toxic based on a person’s unique inherited genetic variability."

Sources:
Press release: IU School of Medicine and Indiana University Health; available at http://news.medicine.iu.edu/releases/201...digm.shtml

http://www.cancer.iu.edu/ [Accessed 16 May 2014].
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