A controlled study with Niraparib versus physician's choice in patients with previously-treated, HER2 negative, BRCA mutation-positive breast cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 306

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.
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; either relapsed while on adjuvant endocrine treatment or wihtin one year of completing adjuvant endocrine treatment, or progression on at least on line of endocrine treatment for advanced cancer.
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 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 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 = 50 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 who are sexually active and their partners must agree to the use of a highly effective form of contraception throughout their participation during the st

Exclusion Criteria

No exclusion criteria are defined per protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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