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临床试验/CTRI/2020/12/030021
CTRI/2020/12/030021已完成4 期

A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India

Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
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试验速览

阶段
4 期
状态
已完成
发起方
入组人数
200
研究概览入排标准研究者记录与标识符相似试验

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

入选标准

  • •Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
  • •Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
  • •Have postmenopausal status
  • •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • •Have adequate organ function
  • •Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy
  • •Are able to swallow oral formulation

排除标准

  • •Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
  • •Have clinical evidence or history of central nervous system metastasis.
  • •Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
  • •Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted.
  • •Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • •Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
  • •Have received an autologous or allogeneic stem-cell transplant
  • •Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment.
  • •Are pregnant or breastfeeding.

研究者

发起方
Eli Lilly and Company India Pvt Ltd

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