Status:
COMPLETED
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Lead Sponsor:
AbbVie
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
- Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
- 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.
- Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
- 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
- Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.
- More than 2 prior lines of cytotoxic chemotherapy.
- Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
- Prior taxane therapy for metastatic breast cancer.
- 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.
Key Trial Info
Start Date :
January 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2020
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT01506609
Start Date
January 23 2012
End Date
September 2 2020
Last Update
October 25 2021
Active Locations (120)
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1
University of Alabama at Birmingham - Main /ID# 62994
Birmingham, Alabama, United States, 35233
2
Banner MD Anderson Cancer Ctr /ID# 118695
Gilbert, Arizona, United States, 85234
3
University of Arkansas for Medical Sciences /ID# 60750
Little Rock, Arkansas, United States, 72205
4
Moore UC San Diego Cancer Center /ID# 60754
La Jolla, California, United States, 92093