A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT01905592
Phase
PHASE3
Status
Terminated

Conditions

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Carcinoma of Breast
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Neoplasms, Breast
  • Ovarian Neoplasms

Eligibility Criteria

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

Interventions

  • niraparib — DRUG
    300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
  • Physician's choice — DRUG
    Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops

Study Details

The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice

Key Dates

Start date
Feb 25, 2014
Status verified
Oct 2022
Primary completion
May 23, 2018
Completion
Oct 26, 2021

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Physician's choice
    Physician may select from 4 active comparators
  • Experimental: niraparib
    Patients will be randomized 2:1 to receive niraparib 300 mg (3x100 mg capsules) once daily for 21 continuous days

Primary Outcome Measure

Progression Free Survival (PFS) - Central Review Assessment [ Time Frame: From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years ]

Locations (25)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteTucsonArizona85710-
GSK Investigational SiteLos AngelesCalifornia90033-
GSK Investigational SiteLos AngelesCalifornia90048-
GSK Investigational SiteFort MyersFlorida33901-
GSK Investigational SiteMiamiFlorida33176-
GSK Investigational SiteBostonMassachusetts02111-
GSK Investigational SiteOmahaNebraska68114-
GSK Investigational SiteHendersonNevada89074-
GSK Investigational SiteClifton ParkNew York12065-
GSK Investigational SiteLake SuccessNew York11042-
GSK Investigational SiteClevelandOhio44195-
GSK Investigational SiteEugeneOregon97401-
GSK Investigational SitePortlandOregon97225-
GSK Investigational SitePhiladelphiaPennsylvania19111-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteNashvilleTennessee37232-
GSK Investigational SiteDallasTexas75237-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteSan AntonioTexas78217-
GSK Investigational SiteWebsterTexas77598-
GSK Investigational SiteWeslacoTexas78596-
GSK Investigational SiteLow MoorVirginia24457-
GSK Investigational SiteEverettWashington98201-
GSK Investigational SiteSeattleWashington98111-
GSK Investigational SiteGreen BayWisconsin54311-

Find similar trials in Tucson, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Tucson, AZGSK Investigational Site· Los Angeles, CAGSK Investigational Site· Fort Myers, FLGSK Investigational Site· Miami, FLGSK Investigational Site· Boston, MAGSK Investigational Site· Omaha, NE

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