SWOG S1416

Clinical Trial Title Cisplatin With or Without Veliparib in Recurrent or Metastatic Triple-Neg and/or BRCA Breast Cancer With or Without Brain Metastases
Trial Status Closed to Enrollment
Start Date 02/08/2017
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description 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 or has or has not spread to the brain. 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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.
Eligibility Criteria
  • Patients must have metastatic breast cancer and be HER2 non-over expressing per 2013 ASCO-CAP HER testing guidelines (0 or 1+ by IHC; and/or HER2 ratio < 2.0 and HER2 copy number < 4 signals/cell by ISH)
     
  • Patients must be women or men ≥ 18 years of age
     
  • Patients must have a performance status of 0-2 by Zubrod criteria
     
  • Patients must also meet at least one of the following criteria:
  •     Triple Negative: Histologically confirmed primary and/or metastatic site that is ER-negative (≤ 1%), PR-negative (≤ 1%), and HER2–negative
  •     BRCA mutation: Previously confirmed deleterious BRCA1 or 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 had ≤ 1 prior cytotoxic regimen for metastatic disease
     
  • Patients must have completed any prior radiation therapy and hormonal therapy at least 14 days prior to registration
     

  • Patients must not have received prior cisplatin or PARP inhibitors. Prior carboplatin in the adjuvant/neoadjuvant setting is allowed, if completed more than 12 months prior to study entry

  • Patients must not have received any chemotherapy within 14 days prior to registration

  • Patients must not have received any immunotherapy, biologic or any investigational drug within 28 days prior to registration. Patients must not have received bevacizumab within 42 days prior to registration

  • Patients may receive bisphosphonates or denosumab concurrently with study treatment provided it has been started at least 7 days prior to registration

  • Patients must have recovered to ≤ Grade 2 following a significant adverse event or toxicity attributed to previous anti-cancer treatment except neurotoxicity which must be ≤ Grade 1

  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02595905
Principal Investigator Jacqueline Vuky, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org