Terminated • Phase III • Stage III, IV • HER2 negative • Post-Menopausal • Interventional
The following is imported from ClinicalTrials.gov:
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
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
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.
Actual study start date:
February 25, 2014
Ages eligible for study:
18 - 999
Sexes eligible for study:
Arms and Intervention
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
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.