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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
研究概览
简要总结
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Abemaciclib + NSAI or Fulvestrant
Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care.
干预措施: Abemaciclib (Drug)
Abemaciclib + NSAI or Fulvestrant
Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care.
干预措施: Nonsteroidal Aromatase Inhibitor (NSAI) (Drug)
Abemaciclib + NSAI or Fulvestrant
Participants received abemaciclib 150 milligram (mg) orally twice daily, on days 1 through 28 of a 28-day cycle, for up to 6 cycles or less in case of disease progression, or any other discontinuation criterion is met, plus either NSAI (nonsteroidal aromatase inhibitors - anastrozole or letrozole) administered orally as per standard of care or fulvestrant administered intramuscularly as per standard of care.
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event
时间窗: Baseline until end of follow-up (Up To 7 Months)
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that started at the time of, or after the, first study medication administration as well as those events that started prior to the first study drug administration, but which worsened after the first study medication administration. The reported data reflects the unique percentage of participants who experienced any serious and other non-serious adverse events. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Percentage of Participants Who Discontinued From Study Treatment Due to Adverse Events(Baseline until end of study treatment (Up To 6 Months))