A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients
NCT03945721 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-09-29
Summary
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Conditions
- Triple Negative Breast Cancer
- Residual Disease
Interventions
- DRUG
-
Niraparib
Niraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
- RADIATION
-
Radiation Therapy
radiation therapy
Sponsors & Collaborators
-
Tesaro, Inc.
collaborator INDUSTRY -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Alice Ho, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-11
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
NCT03368729 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)
NCT03109080 ·Status: COMPLETED ·Phase: PHASE1
-
Atezolizumab + Stereotactic Radiation in Triple-negative Breast Cancer and Brain Metastasis
NCT03483012 ·Status: COMPLETED ·Phase: PHASE2
-
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
NCT04673448 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
NCT00938652 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer
NCT03979911 ·Status: UNKNOWN
-
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
NCT03106077 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
NCT05919108 ·Status: RECRUITING ·Phase: PHASE2
-
Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency
NCT05461690 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
NCT05498155 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab
NCT00301899 ·Status: COMPLETED ·Phase: PHASE2
-
Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis
NCT06137651 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
NCT04333706 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
NCT04683679 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
NCT01905592 ·Status: TERMINATED ·Phase: PHASE3
-
Triple Negative Breast Cancer Trial
NCT00532727 ·Status: UNKNOWN ·Phase: PHASE3
-
Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer
NCT05522491 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Enzalutamide, Enzalutamide in Combination With Mifepristone, or Chemotherapy in People With Metastatic Breast Cancer
NCT06099769 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer
NCT01167192 ·Status: TERMINATED ·Phase: PHASE2
-
An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
NCT01130259 ·Status: NO_LONGER_AVAILABLE
-
A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
NCT00813956 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
NCT01173497 ·Status: COMPLETED ·Phase: PHASE2
-
Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer
NCT02657889 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
NCT00951054 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer
NCT04690855 ·Status: TERMINATED ·Phase: PHASE2