Trial Search Results
The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 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.
- Drug: Placebo
- Drug: Veliparib
- Drug: Carboplatin
- Drug: Temozolomide
- Drug: Paclitaxel
- 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
- 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.
- 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
- Pregnant or breastfeeding.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study