EUCTR2013-000684-85-ITActive, not recruitingNot Applicable
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 cancerpatients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- 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. Germline BRCA1 or BRCA2 mutation that is considered deleterious or suspected deleterious (include those mutations or translocations termed deleterious” or suspected deleterious” according to Myriad reporting) by analysis at a reference laboratory (Myriad Genetic Laboratories, Salt Lake City, UT, USA, or Myriad GmbH, Martinsried, Germany).
- •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 that included a taxane and anthracycline, if not contraindicated.
- •7. Prior therapy should have included an anthracycline and a taxane (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.
- •8. Patients must not have received anticancer chemotherapy, 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 is 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 must not be platinum resistant defined as: progression of cancer during or within 6 months of completion of prior platinum treatment.
- •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 cells/µL
- •c. Hemoglobin = 9 g/dL
- •d. Serum creatinine = 1.5 × upper limit of normal (ULN) or = 60 mL/min using Cockcroft-Gault equation
- •e. Total bilirubin = 1.5 × ULN OR direct bilirubin = ULN
- •f. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × ULN or < 5 × ULN with liver metastases
- •13. Patients able to swallow and retain oral tablets
- •14. Female patients must not be pregnant or breast feeding
- •a. Female patient of childbearing potential must have a negative serum pregnancy test.
- •15. Patients of child bearing potential and their partners with whom they are sexually active must agree to the use of 2 highly effective forms of contraception from randomization, throughout the study and until 3 months after the l
Exclusion Criteria
- •No exclusion criteria are defined per protocol
Investigators
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