NL-OMON55315已完成3 期
A randomized, multicenter, double-blind phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease - EFC15935/AMEERA-5
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Adult participants with loco-regional recurrent or metastatic disease not
- •amenable to curative treatment
- •-Confirmed diagnosis of ER+/HER2- breast cancer
- •-No prior systemic treatment for loco-regional recurrent or metastatic disease
- •-Measurable disease ie, at least one measurable lesion evaluable per Evaluation
- •Criterion in Solid Tumors (RECIST) v.1.1, or non-measurable bone only disease
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- •-Participants should be willing to provide tumor tissue
- •-Capable of giving informed consent
排除标准
- •-Known active brain metastases
- •-Prior neo (adjuvant) treatment with any selective estrogen receptor degrader
- •-Inadequate organ and marrow function
- •-Disease recurrence while on, or within 12 months of completion of
- •(neo)adjuvant aromatase inhibitor-containing therapy
- •-Pregnant, breastfeeding, or woman of child bearing potential unwilling to use
- •recommended contraception methods
- •-Male participants who disagree to follow contraception
- •-Participants with advanced, symptomatic visceral spread, that are at risk of
- •life-threatening complications in the short term
- •-Participants with significant concomitant illness
研究者
相似试验
已完成
3 期
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapyCLLNL-OMON44081HOVO5
已完成
3 期
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic AlterationsUrothelial Carcinoma10046447bladder cancerNL-OMON55032QED Therapeutics, Inc.5
已完成
3 期
Phase III, pivotal, multicentre, randomised, double-blind controlled Study to evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head.NL-OMON45063Bone Therapeutics6
已完成
3 期
A Phase 3 Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosisprimary amyloidosisprimary systemic amyloidosis (PSA)10035227NL-OMON50586Millenium Pharmaceuticals7
已完成
3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A InfectioNL-OMON48779Janssen-Cilag26