A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Stopped early · Phase 3

Conditions studied: Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Neoplasms

In brief

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

Key facts

Study ID

NCT01905592

Run by

Tesaro, Inc.

People needed

216

Starts

2014-02-25

Expected to finish

2021-10-26

Last updated by the study team

2022-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Henderson, Nevada, United States
• GSK Investigational Site — Clifton Park, New York, United States
• GSK Investigational Site — Lake Success, New York, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Eugene, Oregon, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Webster, Texas, United States
• GSK Investigational Site — Weslaco, Texas, United States
• GSK Investigational Site — Low Moor, Virginia, United States
• GSK Investigational Site — Everett, Washington, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Green Bay, Wisconsin, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.