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Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

NCT03368729 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Niraparib

Niraparib is an oral PARP-1 and -2 inhibitor with high potency.

DRUG

Trastuzumab

Trastuzumab is a commercially available agent administered by intravenous infusion. A loading dose of 8 mg/kg will be given as the first dose followed with all subsequent doses of 6 mg/kg every 3 weeks.

Sponsors & Collaborators

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Tesaro, Inc.

    collaborator INDUSTRY

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Breast Cancer Research Foundation of Alabama

    collaborator UNKNOWN

  • The V Foundation

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Erica Stringer-Reasor, M.D. · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2027-11-01
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368729 on ClinicalTrials.gov