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 Patients
Description
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 treated with physician's choice
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 patients. Niraparib is an orally active PARP inhibitor.
Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day
cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of
life will be measured. The safety and tolerability will be assessed by clinical review of
adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory
values.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- 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
- 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.
Sites
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California
- Unknown facility, San Jose, California, 95124
-
South Dakota
- Unknown facility, Sioux Falls, South Dakota, 57105
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Israel
- Unknown facility, Tel Hashomer, 52621
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