Cyclophosphamide + Veliparib for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byJoseph Sparano, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of cyclophosphamide and veliparib when given together in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Drugs used in chemotherapy, such as cyclophosphamide, 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. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with veliparib may work better in treating breast cancer.

Research Team

Joseph Sparano, MD

Principal Investigator

Montefiore Medical Center - Moses Campus

Eligibility Criteria

This trial is for adults with advanced or metastatic HER2/neu negative breast cancer who've had prior chemotherapy. They must have a certain level of blood cells, no severe liver/kidney issues, and be able to take oral meds. Pregnant women, those unable to use contraception, or patients with recent seizures or bowel obstructions can't join.

Inclusion Criteria

My cancer is not HER2 positive, as tested on my primary or metastatic tumor.

Your platelet count is at least 100,000 per microliter.

I've had chemotherapy for my cancer, or I have a BRCA1 or BRCA2 mutation.

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Exclusion Criteria

Patients may not be receiving any other investigational agents

I have previously been treated with PARP inhibitors like veliparib or olaparib.

I haven't had radiotherapy in the last 3 weeks or recovered from previous treatment side effects.

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Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Veliparib (PARP Inhibitor)

Trial OverviewThe study tests the combination of Cyclophosphamide (a chemo drug) and Veliparib (which blocks enzymes helping tumor growth) in treating advanced breast cancer. It aims to find the safest doses and observe side effects when these drugs are given together.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (veliparib, cyclophosphamide)Experimental Treatment3 Interventions

Patients receive veliparib orally PO QD and cyclophosphamide PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cyclophosphamide is already approved in Canada, Japan for the following indications: