Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Nega… (NCT02595905) | Clinical Trial Compass
CompletedPhase 2
Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases
United States344 participantsStarted 2016-09-15
Plain-language summary
This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have metastatic and/or recurrent (distant or locoregionally recurrent) breast cancer and be HER2 non-over expressing per 2013 American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) HER testing guidelines (0 or 1+ by immunohistochemistry \[IHC\]; and/or HER2 ratio \< 2.0 and HER2 copy number \< 4 signals/cell by in-situ hybridization \[ISH\])
* Local Regional Recurrence
* In the breast (after preserving therapy)
* In the chest wall (after mastectomy)
* In the ipsilateral/parasternal/infra-or supraclavicular lymph nodes
* In the skin of the chest wall (not breast)
* In the reconstructed breast
* Patients must also meet at least one of the following criteria:
* Triple negative: histologically confirmed primary and/or metastatic site that is estrogen receptor (ER)-negative (=\< 1%), progesterone receptor (PR)-negative (=\< 1%), and HER2-negative
* BRCA mutation: previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required
* Patients must have measurable or non-measurable disease; patients must have a chest/abdominal/pelvis computed tomography (CT) scan (or positron emission tomography \[PET\]/CT of diagnostic quality, conventional or spiral) prior to …
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: Time from registration (randomization) to progression or death due to any cause, assessed up to 5 years