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

Phase 2

Completed

• Conditions: mamma carcinoma; metastatic breast cancer; 10006291

• Registration Number: NL-OMON40393
• Lead Sponsor: AbbVie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

•>= 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.

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival [ Time Frame: Radiographic evaluation every 9 weeks,<br /><br>clinical evaluation every cycle ]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>•Overall Survival [ Time Frame: From Randomization until patient's death or 3<br /><br>years post discontinuation ]<br /><br>•Clinical Benefit Rate (CBR) [ Time Frame: From Randomization until patient's<br /><br>death or 3 years post discontinuation ]<br /><br>•Objective Response Rate [ Time Frame: From Randomization until patient's death<br /><br>or 3 years post discontinuation ] </p><br>