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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:
Enrollment
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Inclusion criteria
Provision of informed consent prior to any study specific procedures
Patients (female) must be 18 years of age.
Clinically or radiologically measurable or evaluable disease defined as: presence of bidimensionally or unidimensionally measurable breast lesion by physical or radiological examination.
Estrogen receptor < 10% for ARM A only
Progesterone receptor = 0 for ARM A only
HER2 negative on primary tumor (HER-2 score of 0 or 1+/2+ with FISH not amplified) for ARM A only
Mutation of BRCA 1 and/or 2 for ARM B only
Patients must have normal organ and bone marrow function, ECOG performance status 0-1 (can be amended for specific populations studies)
Adequate cardiac function: left ventricular ejection fraction (LVEF) at rest measured by echocardiography must be no lower than the local normal limit.
Absence of clinically significant cardiovascular disease (e.g. myocardial infarction, unstable angina), New York Hearth Association (NYHA) grade II or greater congestive hearth failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 12 months prior to day 1 on study
Patients must have voluntarily agreed to participate by given informed consent. Written informed consent must be dated and signed by both patients and investigator
Exclusion criteria
Primary purpose
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Interventional model
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45 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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