Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Part of paid clinical trials in San Diego, California.

Sponsor
AstraZeneca
Study ID
NCT02000622
Phase
PHASE3
Status
Completed

Conditions

  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.
  • Physician's choice chemotherapy — DRUG
    Investigators will declare one of the following regimens: * Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days * Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days * Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days

Study Details

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

Key Dates

Start date
Mar 27, 2014
Status verified
Jan 2026
Primary completion
Dec 9, 2016
Completion
Dec 23, 2025

Study Design

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

Arms

  • Experimental: Olaparib
    Olaparib tablet 300mg bd po
  • Active Comparator: Physician's choice chemotherapy
    Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

Primary Outcome Measure

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) [ Time Frame: Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months. ]

Locations (42)

FacilityCityStateZIPSite coordinators
Research SiteSan DiegoCalifornia92123-
Research SiteSanta RosaCalifornia95403-
Research SiteWhittierCalifornia90602-
Research SiteDenverColorado80204-
Research SiteNew HavenConnecticut06510-
Research SiteWashington D.C.District of Columbia20007-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32804-
Research SitePlantationFlorida33324-
Research SiteColumbusGeorgia31904-
Research SiteMariettaGeorgia30060-
Research SiteChicagoIllinois60612-
Research SiteNilesIllinois60714-
Research SiteWichitaKansas67214-
Research SiteLafayetteLouisiana70506-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02118-
Research SiteBostonMassachusetts02215-
Research SiteDetroitMichigan48201-
Research SiteGrand RapidsMichigan49503-
Research SiteRochesterMinnesota55905-0001-
Research SiteSaint Louis ParkMinnesota55416-
Research SiteJacksonMississippi39202-
Research SiteColumbiaMissouri65212-
Research SiteSt LouisMissouri63131-
Research SiteLebanonNew Hampshire03756-
Research SiteCommackNew York11725-
Research SiteHarrisonNew York10604-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10065-
Research SiteRockville CentreNew York11570-
Research SiteSyracuseNew York13210-
Research SiteCincinnatiOhio45267-
Research SiteClevelandOhio44106-
Research SiteClevelandOhio44195-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19104-
Research SiteSayrePennsylvania18840-
Research SiteGermantownTennessee38138-
Research SiteHoustonTexas77030-
Research SiteTylerTexas75701-
Research SiteBurlingtonVermont05401-

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