MyHealth

Manage your account, request prescriptions, set up appointments & more.

LOG IN
Don't have an account
Contact Us

SWOG S1416

Trial

Clinical Trial Title

SWOG S1416

Trial Status

Open to Enrollment

Start Date

February 8, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer 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

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Friday, December 29, 2017 09:24:11 AM