Trial Search Results

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

The main purpose of the study is to determine if patients with BRCA1 or BRCA2 mutation and metastatic breast cancer can do better with veliparib in combination with temozolomide or carboplatin and paclitaxel with or without veliparib.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:



  • Drug: Placebo
  • Drug: Veliparib
  • Drug: Carboplatin
  • Drug: Temozolomide
  • Drug: Paclitaxel


Phase 2


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

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting