Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Official Title

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

Details

Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups. The safety of each treatment group will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, changes in laboratory determinations, and vital sign parameters. The Clinical Benefit Rate (CBR) and Objective Response Rate (ORR) as well as Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be assessed. Study visits will be conducted according to the protocol schedule and randomization group. Study visits will include physical examination, laboratory blood sample collection, and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram (ECG) will be performed at protocol specified visits.

Keywords

Metastatic Breast CancerPARPTMZTemodalCarboplatinveliparibBRCA2 mutation carrierBreast cancertemozolomideBRCA1 mutation carrierABT-888PaclitaxelRecurrent breast cancerTemodarLocally recurrentBreast NeoplasmsAlbumin-Bound Paclitaxel

Eligibility

You can join if…

Open to people ages 18-99

  • 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.

You CAN'T join if...

  • 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 â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
  • Pregnant or breastfeeding

Locations

  • Ucsd /Id# 60754
    La JollaCalifornia92037United States
  • Cedars-Sinai Medical Center /ID# 96549
    Beverly HillsCalifornia90211United States
  • Cedars-Sinai Medical Ctr /ID# 60760
    Los AngelesCalifornia90048United States
  • The Angeles Clinic and Researc /ID# 60743
    Los AngelesCalifornia90025United States
  • The Angeles Clinic and Researc /ID# 93813
    Los AngelesCalifornia90025United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Study Website
ID
NCT01506609
Phase
Phase 2
Study Type
Interventional
Last Updated