Breast Cancer Clinical Trial

Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors

Summary

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must be at least 18 years of age or older.
Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).
Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual.
Participants who have stable and asymptomatic Central Nervous System (CNS) disease must be receiving a stable (for at least 7 days) or decreasing corticosteroid dose at the time of study entry.
Participants must submit fresh or archived (collected within 24 months of enrollment) Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample to the central laboratory for post-enrollment confirmation of tPALB2 status.
Participants must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments.

Exclusion Criteria:

Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
Participants who have ovarian or prostate cancer.
Participants who have variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening.
Participants who relapsed while receiving platinum based therapy in the adjuvant/curative setting.
Participants progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting.
Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
Participants with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage.
Participants with germline or somatic BRCA1 or BRCA2 mutations.
Participant has systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy.
Participants have previously or are currently participating in a treatment study of an investigational agent within 3 weeks of the first dose of therapy preceding the study.
Participants have received prior systemic cytotoxic chemotherapy, biological therapy, or hormonal therapy for cancer, or received radiation therapy within 3 weeks of the first dose therapy preceding the study.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT05169437

Recruitment Status:

Recruiting

Sponsor:

Tempus Labs

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There are 72 Locations for this study

See Locations Near You

Yuma Regional Medical Center
Yuma Arizona, 85364, United States
Highlands Oncology
Springdale Arkansas, 72762, United States
St Joseph Heritage Health - Fullerton
Fullerton California, 92835, United States
MemorialCare
Long Beach California, 90806, United States
Cancer and Blood Specialty
Los Alamitos California, 90720, United States
St Joseph Health Medical Group - Napa
Napa California, 94558, United States
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States
Sharp Healthcare
San Diego California, 92123, United States
Ridley-Tree Cancer Center
Santa Barbara California, 93105, United States
St Joseph Health Medical Group - Santa Rosa
Santa Rosa California, 95403, United States
Hartford Healthcare
Hartford Connecticut, 06102, United States
Eastern Connecticut Hematology and Oncology
Norwich Connecticut, 06360, United States
Holy Cross
Fort Lauderdale Florida, 33308, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
Ocala Community Cancer Center
Ocala Florida, 34474, United States
University Cancer & Blood Center
Athens Georgia, 30607, United States
Hawaii Cancer Care
Honolulu Hawaii, 96813, United States
Northwest Oncology & Hematology
Rolling Meadows Illinois, 60008, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46845, United States
Goshen Health
Goshen Indiana, 46526, United States
Community Health Network
Indianapolis Indiana, 46250, United States
Beacon Health System
South Bend Indiana, 46601, United States
Pontchartrain Cancer Center
Hammond Louisiana, 70403, United States
The Center for Cancer and Blood Disorders - Maryland
Bethesda Maryland, 20817, United States
Frederick Health
Frederick Maryland, 21702, United States
Maryland Oncology Hematology
Rockville Maryland, 20850, United States
Southcoast Health
Fairhaven Massachusetts, 02719, United States
Sparrow Health
Lansing Michigan, 48912, United States
Central Care Cancer Center
Bolivar Missouri, 65613, United States
Mosaic Life Care
Saint Joseph Missouri, 64507, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
OptumCare Cancer Care
Las Vegas Nevada, 89102, United States
New Jersey Cancer Care and Blood Disorders
Belleville New Jersey, 07109, United States
Englewood Health
Englewood New Jersey, 07631, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Novant Health Inc. - Charlotte
Charlotte North Carolina, 28204, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Novant Health Inc. - Winston-Salem
Winston-Salem North Carolina, 27103, United States
Aultman Medical Group
Canton Ohio, 44708, United States
TriHealth
Cincinnati Ohio, 45220, United States
University Hospitals Seidman
Cleveland Ohio, 44106, United States
OhioHealth
Columbus Ohio, 43214, United States
The Toledo Clinic
Toledo Ohio, 43623, United States
Oklahoma Cancer Specialists
Tulsa Oklahoma, 74146, United States
Oregon Oncology Specialists
Salem Oregon, 97301, United States
Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Bon Secours - St. Francis Cancer Center
Greenville South Carolina, 29607, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sanford Health
Sioux Falls South Dakota, 57117, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Texas Oncology - Austin Midtown
Austin Texas, 78705, United States
Texas Oncology - Austin Central Pharmacy
Austin Texas, 78731, United States
Texas Oncology - South Austin
Austin Texas, 78745, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Oncology Consultants
Houston Texas, 77030, United States
Texas Oncology - Longview Cancer Center
Longview Texas, 75601, United States
Texas Oncology - Palestine Cancer Center
Palestine Texas, 75801, United States
Texas Oncology - Paris Cancer Center
Paris Texas, 75460, United States
Lumi Research
Sugar Land Texas, 77479, United States
Texas Oncology - Tyler Pharmacy
Tyler Texas, 75702, United States
Community Cancer Trials of Utah
Ogden Utah, 84405, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Inova Schar Institute
Fairfax Virginia, 22031, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg Virginia, 22408, United States
Virginia Cancer Institute
Richmond Virginia, 23229, United States
Virginia Cancer Institute
Richmond Virginia, 23230, United States
PeaceHealth
Bellingham Washington, 98225, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
ThedaCare
Appleton Wisconsin, 54911, United States
SSM Health
Madison Wisconsin, 53717, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

110

Study ID:

NCT05169437

Recruitment Status:

Recruiting

Sponsor:


Tempus Labs

How clear is this clinincal trial information?

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