Cisplatin + Veliparib for Breast Cancer

Recruiting at 933 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Cisplatin, PARP inhibitors

Disqualifiers: Hearing impairment, AML/MDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 48

Duration: Up to 54 weeks

344 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back (recurrent) or has or has not spread to the brain (brain metastases). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. It is not yet known if cisplatin is more effective with or without veliparib in treating patients with triple-negative and/or BRCA mutation-associated breast cancer.

Research Team

Eve T Rodler

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Inclusion Criteria

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.

Your blood needs to have a certain amount of white blood cells, red blood cells, and platelets.

Patients of childbearing potential must not be pregnant (negative pregnancy test) or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen; men and women of reproductive potential must have agreed to use an effective contraceptive method for 6 months after completion of study treatment

Exclusion Criteria

I haven't had cisplatin or PARP inhibitors, but carboplatin over a year ago is okay.

I have not had chemotherapy in the last 14 days.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cisplatin with or without veliparib. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Up to 54 weeks

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

54 weeks

Every 9 weeks

Long-term Follow-up

Participants are monitored every 18 weeks until progression, and then every 6 months for up to 5 years.

Up to 5 years

Every 18 weeks until progression, then every 6 months

Treatment Details

Interventions

• Cisplatin
• Veliparib

Trial Overview 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.

Participant Groups

Group I: Arm II (cisplatin and veliparib) Experimental Treatment 3 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 Control 3 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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+