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Alkylating agents

Cisplatin + Veliparib for Breast Cancer

Phase 2

Waitlist Available

Led By Eve T Rodler

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

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 be able to swallow whole capsules

Must not have

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

Patients must not have treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or features suggestive of AML/MDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing cisplatin with or without veliparib to treat patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer.

Who is the study for?

This trial is for adults with recurrent or metastatic triple-negative breast cancer and/or BRCA mutation-associated breast cancer, which may include brain metastases. Participants must not be pregnant or nursing, agree to use contraception, have adequate organ function and no history of certain cancers or uncontrolled illnesses. Prior treatments must meet specific criteria.

What is being tested?

The effectiveness of cisplatin chemotherapy with or without the addition of veliparib (a PARP inhibitor) is being tested in patients. The study aims to determine if preventing tumor cells from repairing DNA mutations using veliparib enhances treatment outcomes compared to cisplatin alone.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts; and for veliparib specifically: digestive issues, taste changes, low blood cell counts leading to anemia or bleeding risks.

Eligibility Criteria

Inclusion Criteria

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

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Participants must have breast cancer that is negative for estrogen receptor (ER), progesterone receptor (PR), and HER2, or have a known harmful BRCA1 or BRCA2 gene mutation.

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I can swallow pills without any issues.

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My breast cancer has spread, and it is not HER2 positive according to tests.

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My liver tests are within the required range.

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I have brain metastases and meet specific health criteria.

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I had a full medical check-up in the last 28 days.

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I have not had any other cancer types, except for certain allowed cases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had chemotherapy in the last 14 days.

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I do not have leukemia or myelodysplastic syndrome related to previous treatments.

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I haven't taken any immunotherapy, biologic, or experimental drugs in the last 28 days, nor bevacizumab in the last 42 days.

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I have not had a bone marrow or cord blood transplant from a donor.

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I do not have severe numbness or pain in my hands or feet.

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My hearing is mostly fine, with no major issues.

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

Progression-free survival (PFS)

Secondary study objectives

Clinical benefit rate

Overall survival (OS)

Response rate (measurable disease only)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (cisplatin and veliparib)Experimental Treatment3 Interventions

Patients receive cisplatin IV over 1 hour on day 1 and veliparib PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (cisplatin and placebo)Active Control3 Interventions

Patients receive cisplatin IV over 1 hour on day 1 and placebo PO BID on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Veliparib

2012

Completed Phase 3

~4780