PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations

Part of paid clinical trials in Fullerton, California.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT01074970
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cisplatin — DRUG
    Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
  • Rucaparib — DRUG
    Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
  • Cisplatin — DRUG
    Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

Study Details

The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.

Key Dates

Start date
Feb 28, 2010
Status verified
Sep 2024
Primary completion
Dec 15, 2018
Completion
Dec 15, 2018

Study Design

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

Arms

  • Active Comparator: Arm A: Cisplatin Monotherapy
    Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
  • Active Comparator: Arm B: Combination Therapy
    Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles

Primary Outcome Measure

Two-year Disease Free Survival [ Time Frame: 24 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
St. Jude Heritage HealthcareFullertonCalifornia92835-
University of California Los AngelesLos AngelesCalifornia90095-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
University of Colorado Cancer CenterAuroraColorado80045-
Memorial Cancer Institute Breast Cancer CenterHollywoodFlorida33021-
University of Miami, Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Community Regional Cancer CenterIndianapolisIndiana46256-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Horizon Oncology Research, Inc./IU Health ArnettLafayetteIndiana47905-
Monroe Medical AssociatesMunsterIndiana46321-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
Metro Health Cancer CareWyomingMichigan49519-
Siteman Cancer CenterSt LouisMissouri63110-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
The Center for Cancer & Hematologic DiseaseCherry HillNew Jersey08003-
Virtua Health Cancer ProgramMount HollyNew Jersey08060-
South Jersey Health CareVinelandNew Jersey08360-
Presbyterian Medical GroupAlbuquerqueNew Mexico87110-
University of New Mexico Cancer Center: AlbuquerqueAlbuquerqueNew Mexico87131-
HOPE a Women's Cancer CenterAshevilleNorth Carolina28806-
Seidman Cancer CenterClevelandOhio44106-
Oregon Health Sciences UniversityPortlandOregon97239-
Pinnacle Health Fox Chase Regional Cancer CenterHarrisburgPennsylvania17110-
Bux-Mont Oncology Hematology Associates (FCCC) at Grand View HospitalSellersvillePennsylvania18960-
The West ClinicMemphisTennessee38138-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Fullerton, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
St. Jude Heritage Healthcare· Fullerton, CAUniversity of California Los Angeles· Los Angeles, CACentral Coast Medical Oncology Corporation· Santa Maria, CAUniversity of Colorado Cancer Center· Aurora, COMemorial Cancer Institute Breast Cancer Center· Hollywood, FLUniversity of Miami, Sylvester Comprehensive Cancer Center· Miami, FL

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