A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment (kalitERA)
2026年9月15日 更新者：Hoffmann-La Roche
A Phase IIIb, Single-arm, Open-Label, Multicenter Study Evaluating the Treatment Adherence, Tolerability, and Patient-Reported Outcomes of Giredestrant in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant.
The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
研究概览
研究类型
介入性
注册 (估计的)
1500
阶段
- 第三阶段
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。
学习联系方式
- 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: BO46775 https://forpatients.roche.com/ No attachments to email below.
- 电话号码：888-662-6728 (U.S. Only)
- 邮箱：global-roche-genentech-trials@gene.com
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Histologically confirmed diagnosis of ER-positive, HER2-negative, Stage I-III, breast cancer
- Definitive surgery of primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection and/or sentinel lymph node biopsy)
- Participants must have completed any prior adjuvant chemotherapy before enrollment, if given
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- Adequate organ function
- Men and pre- or perimenopausal women must receive a concurrent approved luteinizing hormone-releasing hormone agonist
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required
- Diagnosis of inoperable locally advanced or Stage IV breast cancer
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS)
- Planned surgery during the study
- Prior treatment with giredestrant, selective estrogen receptor degraders (SERDs), or investigational endocrine agents
- Active cardiac disease or history of cardiac dysfunction
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：非随机化
- 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 |
|---|---|
|
实验性的：Cohort A: Upfront Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
其他名称：
|
|
实验性的：Cohort B: Switch Adjuvant Endocrine Therapy Population
Participants will receive giredestrant.
|
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence of Participants who Have Discontinued Giredestrant for any Reason
大体时间：Month 12
|
Month 12
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Incidence and Severity of Adverse Events (AEs)
大体时间：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Dose Intensity
大体时间：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Treatment Adherence, as Measured by Treatment Duration
大体时间：Up to approximately 5 years
|
Up to approximately 5 years
|
|
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
大体时间：At prespecified timepoints from Baseline until approximately 5 years
|
At prespecified timepoints from Baseline until approximately 5 years
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
|
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
大体时间：Month 6 and Month 12
|
Month 6 and Month 12
|
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。
调查人员
- 研究主任：Clinical Trials、Hoffmann-La Roche
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 (估计的)
2026年10月30日
初级完成 (估计的)
2028年11月30日
研究完成 (估计的)
2032年11月30日
研究注册日期
首次提交
2026年9月15日
首先提交符合 QC 标准的
2026年9月15日
首次发布 (实际的)
2026年9月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月15日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- BO46775
- 2026-526742-27-00 (克蒂斯)
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
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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.