Niraparib + Trastuzumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Erica Stringer-Reasor, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The human epidermal growth factor receptor 2 (HER2) regulates cell growth and survival. Approximately 15-20% of all breast cancers are HER2-positive, which are an aggressive and fast-growing subtype of breast cancer. This study will evaluate a new treatment using a potent Poly polymerase (PARP) inhibitor known as Niraparib. Niraparib will be combined with trastuzumab, a HER2-targeted agent, to evaluate the safety and tolerability in patients with metastatic HER2 positive breast cancer. It is anticipated that the combination of drugs will improve survival and have few side effects.

Research Team

Erica Stringer-Reasor, M.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for women over 18 with aggressive HER2+ metastatic breast cancer who've already tried at least one anti-HER2 therapy. They must be able to take pills, have a heart ejection fraction of ≥50%, and not be pregnant or planning pregnancy during the study. Participants need normal organ/marrow function and measurable disease per RECIST v1.1.

Inclusion Criteria

I can take medicine by mouth.

Signed informed consent

I have tried at least one HER2-targeted therapy for my advanced cancer without success.

Exclusion Criteria

I have received a high dose of doxorubicin or a similar drug.

You have been diagnosed with HIV.

I have recovered from serious side effects of my previous treatments.

Treatment Details

Interventions

• Niraparib (PARP Inhibitor)
• Trastuzumab (Monoclonal Antibodies)

Trial Overview The trial tests Niraparib combined with Trastuzumab in patients with metastatic HER2+ breast cancer to check safety and effectiveness. The goal is to see if this drug combo can improve survival rates while keeping side effects low compared to current treatments.

Participant Groups

Group I: Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kg Experimental Treatment 2 Interventions

The dosage of Niraparib in phase 2 will be determined by the response of patients in Phase 1. A dosage of Niraparib 200 mg will be given along with Trastuzumab 6 mg/kg IV unless a dose limiting toxicity occurs in Phase 1. If so, Niraparib 100 mg will be given with Trastuzumab 6 mg/kg (instead of Niraparib 200 mg).

Group II: Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kg Experimental Treatment 2 Interventions

In phase 1 patients in this first arm will receive 200 mg Niraparib in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.

Group III: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kg Experimental Treatment 2 Interventions

In phase 1 patients in this second arm will receive Niraparib 100 mg in combination with 6 mg/kg Trastuzumab given IV every 3 weeks.

Niraparib is already approved in Canada for the following indications:

Approved in Canada as Zejula for:

• Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Montefiore Bronx, NY

University of Chicago Chicago, IL

University of Alabama at Birmingham Birmingham, AL

University of Washington- Seattle, WA

More Trial Locations

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1677

Patients Recruited

2,458,000+

VFoundation

Collaborator

Trials

1

Patients Recruited

50+

The V Foundation

Collaborator

Trials

10

Patients Recruited

320+

Breast Cancer Research Foundation of Alabama

Collaborator

Trials

2

Patients Recruited

70+

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Patients Recruited

220,000+

Translational Breast Cancer Research Consortium

Collaborator

Trials

27

Patients Recruited

3,100+

Tesaro, Inc.

Industry Sponsor

Trials

57

Patients Recruited

10,600+