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Alkylating agent

Veliparib + Carboplatin for Breast Cancer

Phase 1

Waitlist Available

Led By Kai C Johnson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

Summary

This trial is testing the combination of veliparib and carboplatin to treat patients with HER2-negative breast cancer that has spread. Veliparib may help carboplatin kill more cancer

Who is the study for?

This trial is for patients with HER2-negative metastatic breast cancer, particularly those whose tumors lack a certain repair pathway (FA deficiency) or have a BRCA1/2 mutation. Participants can have had up to three prior chemo treatments but must be four weeks out from the last one. They should be in relatively good health (ECOG <= 2), may have treated brain metastases, and meet specific blood cell count criteria.

What is being tested?

The study is testing the combination of Veliparib, which might stop tumor cells from repairing DNA damage, with Carboplatin, a chemotherapy drug that damages cancer cell DNA. The goal is to see if this combo works better than Carboplatin alone at killing tumor cells in patients with advanced breast cancer.

What are the potential side effects?

Potential side effects include those common to chemotherapy like fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems. Veliparib could also cause additional issues such as digestive upset or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is ER/PR positive, HER2 negative, and lacks the FA pathway.

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My cancer is HER negative and I have a BRCA1/2 gene mutation.

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I can take care of myself but might not be able to do heavy physical work.

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My breast cancer is triple-negative.

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I have Gilbert syndrome with high bilirubin levels.

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I have treated brain metastases and my doctor expects me to live more than 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events to measure the safety and tolerability of this treatment combination

Secondary study objectives

Clinical response (complete and partial response as well as stable and progressive disease)

Other study objectives

Circulating tumor cell markers

PARP-1 activity

Thymidine kinase uptake on 3'-[F-18]fluoro-3'-deoxythymidine positron emission tomography (FLT-PET) scans

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (veliparib, F 18 fluorothymidine, carboplatin)Experimental Treatment6 Interventions

Patients receive carboplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-7 or 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo fluorothymidine PET scan and peripheral blood cell and tumor tissue collection periodically for correlative studies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Carboplatin

FDA approved

Computed Tomography

2017