A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)
2020年1月10日 更新者：Eli Lilly and Company
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
研究概览
研究类型
介入性
注册 (实际的)
132
阶段
- 阶段2
扩展访问
可用的
查看扩展访问记录。
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Brussel、比利时、1000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charleroi、比利时、6000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Leuven、比利时、3000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Liège、比利时、4000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dijon、法国、21034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris、法国、75248
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Sedona、Arizona、美国、86336
- Northern Arizona Hematology & Oncology Associates
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Tucson、Arizona、美国、85715
- Arizona Clinical Research Center
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Tucson、Arizona、美国、85704
- HOPE Hematology Oncology Physicians and Extenders
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California
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San Francisco、California、美国、94115
- Univ of California San Francisco
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Santa Barbara、California、美国、93105
- Sansum Medical Research Foundation
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Colorado
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Denver、Colorado、美国、80220
- Rocky Mountain Cancer Center
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District of Columbia
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Washington、District of Columbia、美国、20010
- Washington Hospital Center
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Florida
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Fort Myers、Florida、美国、33916
- Florida Cancer Specialists
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Miami、Florida、美国、33176
- Advanced Medical Specialties
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Saint Petersburg、Florida、美国、33705
- Florida Cancer Specialists
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Maryland
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Columbia、Maryland、美国、21044
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis、Minnesota、美国、55404
- Minnesota Oncology/Hematology PA
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cincinnati、Ohio、美国、45242
- Oncology Hematology Care Inc
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Tennessee
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Nashville、Tennessee、美国、37203
- Sarah Cannon Research Institute SCRI
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Texas
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Austin、Texas、美国、78731
- Texas Oncology Cancer Center
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Bedford、Texas、美国、76022
- Texas Oncology - Bedford
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Dallas、Texas、美国、75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas、Texas、美国、75231
- Presbyterian Hospital Dallas
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Fort Worth、Texas、美国、76104
- The Center for Cancer and Blood Disorders
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Houston、Texas、美国、77024
- Texas Oncology-Memorial City
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Plano、Texas、美国、75093
- Texas Oncology-Plano West
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Sherman、Texas、美国、75090-0504
- Texas Oncology-Sherman
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The Woodlands、Texas、美国、77380
- US Oncology
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Tyler、Texas、美国、75702
- Tyler Cancer Center
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Washington
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Vancouver、Washington、美国、98684
- Northwest Cancer Specialists PC
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Barcelona、西班牙、08035
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid、西班牙、28007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia、西班牙、46015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria.
- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
Prior treatment with at least 2 chemotherapy regimens:
- At least 1 of these regimens must have been administered in the metastatic setting.
- At least 1 of these regimens must have contained a taxane.
- No more than 2 prior chemotherapy regimens in the metastatic setting.
- Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
- Have discontinued all previous therapies for cancer.
- Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.
Exclusion Criteria:
- Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
- Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
- Have had major surgery within 14 days of the initial dose of study drug.
- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle).
Participants may continue to receive treatment until discontinuation criteria are met.
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口服给药
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
大体时间：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Overall Survival (OS)
大体时间：From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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OS defined as the time from first dose date to the date of death due to any cause.
For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
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From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
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Duration of Response (DOR)
大体时间：From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier.
CR and PR were defined using the RECIST v1.1.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
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From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Progression Free Survival (PFS)
大体时间：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause.
Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant.
If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
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Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
大体时间：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
大体时间：From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months.
CR, PR, or SD were defined using RECIST, v1.1 criteria.
CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.
PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.
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From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
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Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
大体时间：Cycle 6 Day 1
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A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
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Cycle 6 Day 1
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Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
大体时间：Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20
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Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
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Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
大体时间：Cycle 6 Day 1
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EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties.
A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines.
For functional domains and global health status, higher scores represent a better level of functioning.
For symptoms scales, higher scores represented a greater degree of symptoms.
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Cycle 6 Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年6月10日
初级完成 (实际的)
2016年4月30日
研究完成 (实际的)
2018年10月22日
研究注册日期
首次提交
2014年3月31日
首先提交符合 QC 标准的
2014年3月31日
首次发布 (估计)
2014年4月3日
研究记录更新
最后更新发布 (实际的)
2020年1月21日
上次提交的符合 QC 标准的更新
2020年1月10日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 15419
- I3Y-MC-JPBN (其他标识符：Eli Lilly and Company)
- 2013-005548-27 (其他标识符：EudraCT Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共享时间框架
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.