A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer - M12-895

AbbVie B.V.0 个研究点目标入组 7 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•>= 18 years of age, male and female.
•Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
•Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
•If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
•Subject has measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
•Subject must have adequate bone marrow, renal and hepatic function.
•Subject must not be pregnant or plan to conceive a child.

•Received anticancer agent(s), an investigational agent within 21 days prior, or radiotherapy within 28 days prior Cycle 1 Day 1
•More than 2 prior lines of cytotoxic chemotherapy
•Prior therapy with temozolomide, a platinum agent, or a PARP (Poly (ADP-ribose) - Polymerase) inhibitor.
•Prior taxane therapy for metastatic disease
•A history of or evidence of brain metastases or leptomeningeal disease.
•A history of uncontrolled seizure disorder
•Pre-existing neuropathy from any cause in excess of Grade 1
•Known history of allergic reaction to cremophor/paclitaxel
•Clinical significant uncontrolled conditions - active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
•Pregnant or breastfeeding

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