West Cancer Center

BREAST: Metastatic; BRCA mutant; "M12-895"

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

Title

Abbott M12-895

Study Title

Site Link

NCT01506609

Malignancy

Breast, Metastatic Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic palliative

Line Of Therapy

1st line2nd line3rd line

Investigational Agent

Veliparib

Drug Class

PARP inhibitor

Lee Schwartzberg, MD

Sponsor

AbbVie (Abbott)

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01506609?term=M12-895&rank=1

Key Eligibility Criteria Details

Unresectable recurrent or metastatic disease
BRCA1 or BRCA2 germline mutation
ECOG 0-2
If HER2 positive, must have either progressed on HER2 tx or ineligible to receive HER2 tx
No more than 2 prior lines of cytotoxicchemotherapy
No prior taxane therapy in metastatic setting
No brain mets or history of brain mets
Not pregnant or breastfeeding_

Objective

Primary- PFS; Secondary- OS, CBR, ORR, Chemo-induced neuropathy

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

BRCA germline mutation

Dosing Frequency

Veliparib Day 1-7 and temozolomide Day 1-5 of 28 day cycle; Veliparib Day 1-7 and Carbo/Taxol Day 3 of 21 day cycle;

Control Agents

Placebo, temozolomide, carbo/taxol

Study Protocol

Randomized

Yes