Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03368729
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib is an oral PARP-1 and -2 inhibitor with high potency.
  • Trastuzumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 6, 2019
Status verified
Jan 2026
Primary completion
Nov 1, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Niraparib 200 mg + Trastuzumab 6 mg/kg
    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.
  • Experimental: Phase 1: Niraparib 100 mg + Trastuzumab 6 mg/kg
    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.
  • Experimental: Phase 2: Niraparib 200 mg or 100 mg + Trastuzumab 6 mg/kg
    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).

Primary Outcome Measure

Phase 1: Dose-limiting toxicity (DLT) [ Time Frame: Baseline to 6 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of ChicagoChicagoIllinois60637-
Mayo ClinicRochesterMinnesota55905-
MontefioreThe BronxNew York10461-
University of North CarolinaChapel HillNorth Carolina27599-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Washington-SeattleWashington98109-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Chicago· Chicago, ILMayo Clinic· Rochester, MNMontefiore· The Bronx, NYUniversity of North Carolina· Chapel Hill, NCUniversity of Pennsylvania· Philadelphia, PA

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