http://breast-cancer-research.com/content/11/1/201
Of interest:
"In contrast to the classical design, in which an experimental therapy is compared with a standard therapy, examples of novel designs are available amongst the ongoing anti-HER2 neoadjuvant studies: the so-called 'biological window' design and 'learn on the way' design. The biological window design exposes the patients to a short period of therapy with the drug of interest alone to allow for the evaluation of biologic endpoints. This design can also provide valuable insight regarding drug pharmacodynamics and early evidence of drug activity and highlight potential mechanisms of resistance. As this phase of design is purely for research purposes and does not offer patients direct therapeutic benefit, there are ethical concerns that must be respected. A short biological window period can be followed by a more classical design comparing standard neoadjuvant therapy with new combinations, including targeted therapy with curative intent, such as in the neoALTTO trial. In the future, these studies may lead to a reduction in over-treatment with chemotherapy, as they may identify patients with excellent response to the targeted therapy alone that can be evaluated in a future chemotherapy-sparing study."
This is the study we are waiting for.
Hopeful
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