Treatment selection for breast cancer is still largely empiric and guided by large randomized clinical trials on populations of patients. This approach is inadequate for the selection of individualized chemotherapy regimens. Estimates of benefits for individuals are extrapolations from the effects seen in these large trials, and do not necessarily apply to individual patients. The revolution in genomics promises to transform oncology care. By better defining cancer subtypes, a better understanding of breast cancer biology should help to guide treatment. The up-front phase we have decide to adopt play a pivotal role as it is useful for testing a targeted therapeutic drug such as olaparib wich also requires development of new biomarkers which may be useful for future studies. With this approach it could be possible to demonstrate drug target or biomarker effect in clinical setting and models the relationship between the pharmacodynamics and the pharmacokinetics. Additional benefits of this approach include the following: * It could facilitate rational drug selection, identify therapeutic failures early, and compress timelines for anticancer drug development. * It could provide initial rationale and guiding principles for further drug development based on studies in humans (rather than xenografts, where tissues of one species are transplanted to another species). * As it focuses on extensively characterizing how a drug works and whether it hits its intended target (including molecular imaging studies) in a limited number of patients it could yield results that would optimally inform and expedite the subsequent development of molecularly-targeted agents
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Correlation between baseline gene and protein expression profile and clinical response
Time frame: Duration of the study
Assess overall response rate by RECIST criteria evaluated clinically in each treatment group
Time frame: Through study completion, an average of 1 year
Evaluate safety and tolerability of olaparib alone assessed by CTCAE v4.0
Time frame: Through study completion, an average of 1 year
Compare time to deterioration of health-related quality of life by QLQ-C30 scale
Time frame: Through study completion, an average of 1 year
Compare health status by QLQ-C30 scale
Time frame: Through study completion, an average of 1 year
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