Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04584255
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Breast Cancer
  • Deleterious PALB2 Gene Mutation
  • Germline BRCA1 Gene Mutation
  • Germline BRCA2 Gene Mutation
  • HER2-negative Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Predetermined dosage PO Daily
  • Dostarlimab — DRUG
    Predetermined Dosage, IV,q3 weeks

Study Details

This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations. The names of the study drugs involved in this study are: * Niraparib (Zejula) * Dostarlimab

Key Dates

Start date
Dec 18, 2020
Status verified
May 2026
Primary completion
Jul 1, 2025
Completion
Jul 17, 2029

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Triple Negative Breast Cancer (TNBC)
    Participants will be randomized 1:1 to treatment with the combination (Arm A) * Niraparib-Daily beginning with week 1, day 1 * Dostarlimab-Once every three weeks beginning with week 1, day 1
  • Experimental: Arm B TNBC
    Participants will be randomized 1:1 to treatment with the combination (Arm B) * 3-week lead-in of niraparib monotherapy followed by treatment with the combination * Niraparib Daily beginning with week 1, day 1 * Dostarlimab Once every three weeks beginning with week 4, day 1
  • Experimental: Arm C ER+/HER2-
    exploratory cohort of estrogen receptor (ER) positive HER2-negative participants will be enrolled to Arm C. * Niraparib Daily beginning with week 1, day 1 * Dostarlimab Once every three weeks beginning with week 1, day 1

Primary Outcome Measure

Tumor-infiltrating lymphocytes (TILs) [ Time Frame: baseline to 21 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Yale University Cancer CenterNew HavenConnecticut06520-
Johns Hopkins UniversityBaltimoreMaryland21287-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
University of Washington / Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in New Haven, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Yale University Cancer Center· New Haven, CTJohns Hopkins University· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAMayo Clinic· Rochester, MN

Related Studies