Clinical Trial VICCBRE1391
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
- Protocol No. VICCBRE1391
- Open Date: 04/24/2014
- Staging: Phase III
- Age Group: Adults
- Scope: International
- Objective: The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic HER2-negative gBRCAmut breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine).
- Disease Sites: Breast
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Capecitabine; Gemcitabine; Halaven (eribulin); Niraparib; Vinorelbine
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01905592
- Secondary Protocol No: TESARO PR-30-5010-C
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.
2. Metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.
3. 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 that included a taxane and/or anthracycline, if not contraindicated.
4. 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 (progression during at least one prior hormonal therapy) for which chemotherapy is indicated.
5. ECOG performance status 0-2
6. Adequate bone marrow, kidney and liver function
1. Patients with platinum resistant cancer
2. Symptomatic uncontrolled brain metastases
3. 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
4. Known hypersensitivity to the components of niraparib
5. Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
6. Pregnant or breast feeding patients
7. Immunocompromised patients
8. Known active Hepatitis B or C
9. Prior treatment with a PARP inhibitor
10. Known history of myelodysplastic syndrome (MDS).
11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.