Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Search by condition
Search By:
Protocol # 20-371

Status

Recruiting

Description

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

Condition

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

Interventions

  • Niraparib
  • Dostarlimab

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Tumor-infiltrating lymphocytes (TILs)
  • The number and proportion of participants achieving Pathologic Complete Response (pCR)

Secondary Outcome:

  • pCR rate (ER+/HER2- BC patients)
  • Changes in TILs
  • Rate of Residual Cancer Burden (RCB) 0/1 response
  • Number of Participants With Treatment-Related NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Enrollment

62

Study Start Date

December 18, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Dana-Farber Cancer Institute

Source

Dana-Farber Cancer Institute

Official title

A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer

Clinicaltrials.gov Identifier

NCT04584255

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.