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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
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
~1940
Veliparib
2012
Completed Phase 3
~4800

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,030 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Eve T RodlerPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02595905 — Phase 2
Breast Cancer Research Study Groups: Arm II (cisplatin and veliparib), Arm I (cisplatin and placebo)
Breast Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02595905 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595905 — Phase 2
~14 spots leftby Oct 2024
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