NL-OMON45039已完成3 期
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 - BRAVO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- TESARO Inc.
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 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, 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 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/*L;b. Platelets * 100,000 cells/*L;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 ch
排除标准
- •The selection criteria listed in the protocol summary and Section 3.2 of the protocol contain many exclusions; they are just stated as selection criteria.
- •The most important are:
- •- Patients must not have symptomatic uncontrolled brain metastases
- •- 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.
- •- Patients must not be platinum resistant defined as: progression of cancer during or within 6 months of completion of prior platinum treatment.
研究者
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