Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Massachusetts General Hospital
Study ID
NCT04837209
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Capsule, taken by mouth
  • Dostarlimab — DRUG
    Intravenous infusion
  • Radiation therapy — RADIATION
    Radio Therapy

Study Details

This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy (RT) is safe and effective in participants with metastatic triple negative breast cancer. The names of the study treatment involved in this study are: * Dostarlimab * Niraparib * Radiation Therapy (RT), which is given per standard of care.

Key Dates

Start date
Jul 21, 2021
Status verified
Sep 2025
Primary completion
Feb 1, 2027
Completion
Dec 1, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib + Dostarlimab + Radiation therapy
    Study cycle length is 3 weeks. Participants will receive: * Niraparib 1x daily during each study cycle * Dostarlimab 1x every 3 weeks for 4 study cycles, then 1x every 6 weeks beginning on Cycle 5 * Radiation therapy will be given on Days 1, 2, and 3 of Cycle 1.

Primary Outcome Measure

Overall response rate (ORR)-RECIST [ Time Frame: Enrollment to end of treatment up to 5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in Washington D.C., DC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sibley Memorial Hospital· Washington D.C., DCMassachusetts General Hospital Cancer Center· Boston, MADuke University Medical Center· Durham, NCUniversity of Pennsylvania Abramson Cancer Center· Philadelphia, PA

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