A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
- Conditions
- mamma carinomametastatic breast cancer10006291
- Registration Number
- NL-OMON44514
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
-Men and women >= 18 years of age;
- Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic;
- Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent;
- Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation;
- Measurable or non-measurable (but radiologically evaluable) disease per RECIST version 1.1 on computed tomography (CT) scan.
- Received anticancer agent(s) or an investigational agent within 21days prior to C1D-2 or radiotherapy within 28 days prior to C1D-2;
- More than 2 prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease;
- More than one prior line of platinum therapy for breast cancer;
- Subjects who have progressed on platinum therapy or recurred within 12 months of platinum therapy will be excluded;
- Prior therapy with PARP inhibitors;
- Prior taxane therapy administered for the treatment of metastatic breast cancer with exceptions (see protocol);
- Subjects with active brain metastases or leptomeningeal disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression Free Survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Overall Survival<br /><br>- Clinical Benefit Rate<br /><br>- Objective Response Rate<br /><br>- Progression Free Survival second-line therapy<br /><br>- Duration of Overall Response</p><br>