NCT07827573尚未招募3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- Incidence of Participants who Have Discontinued Giredestrant for any Reason
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort A: Upfront Adjuvant Endocrine Therapy Population
Experimental
Participants will receive giredestrant.
干预措施: Giredestrant (Drug)
Cohort B: Switch Adjuvant Endocrine Therapy Population
Experimental
Participants will receive giredestrant.
干预措施: Giredestrant (Drug)
结局指标
主要结局
Incidence of Participants who Have Discontinued Giredestrant for any Reason
时间窗: Month 12
次要结局
- Treatment Adherence, as Measured by Dose Intensity(Up to approximately 5 years)
- Treatment Adherence, as Measured by Treatment Duration(Up to approximately 5 years)
- Incidence and Severity of Adverse Events (AEs)(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)(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES(Month 6 and Month 12)
- Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES(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(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(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(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(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(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(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)(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(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(Month 6 and Month 12)
- Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES(Month 6 and Month 12)
- Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES(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(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(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(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(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)(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(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492(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(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492(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(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(At prespecified timepoints from Baseline until approximately 5 years)
- Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492(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(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(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(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(Month 6 and Month 12)
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