Editorial urges rapid clinical trials for targeted breast cancer therapies

Chapel Hill, NC – In an editorial published today in the Journal of Clinical Oncology, UNC associate professor E. Claire Dees, MD, reviews current evidence on the safety and efficacy of combination therapies currently used for metastatic breast cancer and urges clinical researchers to move forward with new studies that leverage advances in the identification of tumor biomarkers.

Dees, who is a member of UNC Lineberger Comprehensive Cancer Center and the UNC Breast Center, surveys the evidence comparing utility of combination chemotherapy with single agents in sequence.  She then comments on a clinical trial conducted by the Danish Breast Cancer Cooperative Group, noting that their results confirm prior studies showing that taxane doublets – therapeutic regimens combining a taxane drug with another chemotherapy – have no effect or only a modest effect on improving overall survival compared to therapy with the taxane chemotherapy alone.  This conclusion reinforces the overall consensus in the field of metastatic breast cancer treatment.

She goes on to outline some of the methodological aspects of recent studies that limit researchers ability to correlate drug response with particular tumor features or subtypes.  To overcome this limitation, Dees urges researchers to include assessment of tumor tissue for biomarkers at all phases of drug development and to design trials that efficiently and rapidly evaluate new therapies or combinations of therapies in groups of patients with particular tumor molecular features or signatures.

Research conducted at UNC and elsewhere has identified multiple breast cancer subtypes and confirmed that these subtypes have distinct features and prognoses, making “one size fits all” treatment for breast cancer problematic and encouraging the development of new therapies that target these subtypes.

With this in mind, Dees advocates for the adoption of new clinical trial designs, such as adaptive randomization, to allow studies to move forward quickly – challenging her fellow breast cancer researchers “to design and conduct studies that will allow us to make transformational progress in the therapy of metastatic breast cancer.”

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