Overview

Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer

Status:
Completed
Trial end date:
2017-04-12
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin and to see how well they work in treating patients with human epidermal growth factor 2 (HER2)-negative breast cancer that has spread to other parts of the body. Carboplatin kills cancer cells by damaging the deoxyribonucleic acid (DNA) that lets the cancer cell survive and reproduce. The body has proteins that try to repair the damaged DNA. Veliparib may prevent these proteins from repairing the DNA so that carboplatin may be able to kill more tumor cells. Giving veliparib with carboplatin may kill more tumor cells than carboplatin alone.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Alovudine
Carboplatin
Dideoxynucleosides
Veliparib
Criteria
Inclusion Criteria:

- Patients must have histologically or cytologically proven metastatic or locally
advanced inoperable breast cancer that fulfills one of the following two criteria:

- Triple-negative breast cancer

- ER and/or PR positive, HER2 negative if their tumors have been shown to be
deficient for the FA pathway, based on FA triple stain immunofluorescence (FATSI)
screening

- HER negative with a known germline BRCA1/2 mutation

- Patients with ER- and/or PR-positive breast cancer will be consented to have
their existing, or to be obtained, paraffin-embedded tumor tissue screened
for FA deficiency

- No more than 3 prior chemotherapy regimens for metastatic disease will be allowed; any
number of prior hormone therapies will be allowed; however, at least 4 weeks should
have elapsed since prior chemotherapy (6 weeks for mitomycin C and nitrosoureas and 2
weeks for hormone therapy) or radiation therapy (2 weeks for limited field palliative
radiation to the bone)

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Patients with treated brain metastases and life expectancy of greater than 3 months

- Patients with known Gilbert syndrome with abnormal unconjugated bilirubin will be
eligible

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic acid transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance >= 60
mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- No prior therapy with veliparib for metastatic disease will be allowed

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Ability to understand and the willingness to sign a written informed consent document

- Patients must be able to swallow pills

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to veliparib or other agents used in study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with veliparib

- Known human immunodeficiency virus (HIV)-infected patients on protease inhibitors are
ineligible; HIV-infected patients with adequate cluster of differentiation (CD)4
counts (> 500) and not on protease inhibitors are eligible

- Patients with active seizure or a history of seizures are not eligible

- Patients with uncontrolled central nervous system (CNS) metastasis are not eligible;
patients with CNS metastases must be stable after therapy for > 3 months and off
steroid treatment prior to study enrollment