EUCTR2013-000684-85-GBActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- TESARO Inc.
- Enrollment
- 306
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced breast cancer that is not amenable to resection or radiation with curative intent.
- •2. Female and male patients age at least 18 years.
- •3. Patients with a deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation may be enrolled into the study and randomized based on either local or central laboratory testing of BRCA status (Myriad Genetic Laboratories, Salt Lake City, UT, USA). On- study central confirmation of BRCA status will be performed for those patients who were enrolled based on either a previous Myriad test or a local test. If after inclusion, based on a local test result or a previously done Myriad test, a patient turns out not to have a germline BRCA mutation per central laboratory results (Myriad Genetic Laboratories, Salt Lake City, UT, USA) the patient can still continue on study based on his/her physician discretion and his/her own preference.
- •4. Measurable disease by RECIST v1.1 or non- measurable disease that is clinically evaluable (except sclerotic-only bone disease; bone-only disease that has a lytic component is allowed).
- •5. Patients must not have symptomatic uncontrolled brain metastases To be considered controlled, central nervous system (CNS) disease must have undergone treatment (whole brain radiation, radiosurgery or equivalent) at least 1 month previously and the patient has no new or progressive signs or symptoms related to the CNS disease, and are off steroid therapy two weeks.
- •6. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer (not including adjuvant or neo-adjuvant therapy); 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.
- •7. 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.
- •8. Patients must not have received anticancer chemotherapy, radiotherapy (including palliative radiotherapy), hormonal therapy, biological therapy, or any other investigational therapy within 3 weeks prior to the start of study treatment. Patients with persistent toxicity (except alopecia) > grade 1 from prior cancer therapy will also be excluded. Bisphosphonate and denosumab are allowed.
- •9. No prior treatment with a known or putative PARP inhibitor (except iniparib). No other anticancer agent (chemotherapy, hormonal therapy, or other agent) is to be permitted during the course of the study for any patient.
- •10. Patients who have previously received platinum chemotherapy in the metastatic setting are allowed to enroll in the study as long as they did not progress while on or within 8 weeks from the day of the last platinum administration. Patients who received platinum in the (neo-) adjuvant setting are eligible, as long as they relapsed 12 months or more after the last dose of platinum.
- •11. ECOG performance status 0-2 (Appendix G).
- •12. Adequate organ function (assessed within 72 hours prior to the first dose):
- •a. Absolute neutrophil count (ANC) = 1,500 cells/µL
- •b. Platelets = 100,000 c
Exclusion Criteria
- •No exclusion criteria are defined per protocol
Investigators
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