Phase 2
N=294
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
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01506609 ↗Enrolled (actual)
294
Serious AEs
25.9%
Results posted
Oct 2021
Primary outcome: Primary: Progression-Free Survival (PFS) — 12.3; 14.1; 7.4 months — p=0.227
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Veliparib (Drug); Carboplatin (Drug); Temozolomide (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
12.3; 14.1; 7.4 | 0.227 |
| SECONDARY Overall Survival (OS) |
25.4; 28.3; 19.1 | 0.368 |
| SECONDARY Clinical Benefit Rate (CBR) at Week 18 |
87.0; 90.7; 73.0 | 0.434 |
| SECONDARY Objective Response Rate (ORR) |
61.3; 77.8; 28.6 | 0.027 sig |
| SECONDARY Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score |
13.94; 11.24 | 0.354 |
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 carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01506609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.