Status:
TERMINATED
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Lead Sponsor:
Tesaro, Inc.
Collaborating Sponsors:
European Organisation for Research and Treatment of Cancer - EORTC
Breast International Group
Conditions:
Neoplasms, Breast
Carcinoma of Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those tre...
Detailed Description
This is a phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician's choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer pa...
Eligibility Criteria
Inclusion
- Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.
- Histologically or cytologically confirmed HER2-negative metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.
- Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy.
- Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting.
- a. Hormone receptor positive patients must also have hormone resistant disease; either relapsed while on adjuvant endocrine treatment, or within one year of completing adjuvant endocrine treatment, or progression on at least one line of endocrine treatment for advanced cancer.
- ECOG performance status 0-2
- Adequate bone marrow, kidney and liver function
Exclusion
- Patients with platinum resistant cancer
- Symptomatic uncontrolled brain metastases
- Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval
- Known hypersensitivity to the components of niraparib
- Invasive cancer other than breast cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- Pregnant or breast feeding patients
- Immunocompromised patients
- Known active Hepatitis B or C
- Prior treatment with a PARP inhibitor
- Known history of myelodysplastic syndrome (MDS).
- known and persistent (\>4 weeks) \>/= grade 3 toxicity or fatigue from prior cancer treatment.
Key Trial Info
Start Date :
February 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2021
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01905592
Start Date
February 25 2014
End Date
October 26 2021
Last Update
November 15 2022
Active Locations (104)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85710
2
GSK Investigational Site
Los Angeles, California, United States, 90033
3
GSK Investigational Site
Los Angeles, California, United States, 90048
4
GSK Investigational Site
Fort Myers, Florida, United States, 33901