Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:
A Phase II, Open Label, Controlled Study of Olaparib in Locally Advanced ER, PgR and HER2 Negative (Triple Negative) and in Locally Advanced Germline BRCA Mutation-positive Breast Cancer Patients: Biological Evaluation From a "Window of Opportunity" Trial

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02681562
Study type	Interventional
Source	Istituti Ospitalieri di Cremona
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.