NCT07541079招募中3 期
A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
研究概览
简要总结
The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.
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
- •Considered appropriate for treatment with endocrine therapy (ET)
- •Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
- •Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive
- •Documented HER2- tumor according to ASCO/CAP
- •Postmenopausal females at the time of signing the Informed Consent Form
- •Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months
- •Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent
- •Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment
- •Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance
- •Participant and investigator planning the first switch from an AI
- •Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy
- •Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1
排除标准
- •Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents
- •Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease
- •Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)
- •Have active cardiac disease or history of cardiac dysfunction
- •Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
- •Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- •Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
研究组 & 干预措施
Giredestrant
Experimental
干预措施: Giredestrant (Drug)
结局指标
主要结局
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
时间窗: At 12 months
Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0)
时间窗: From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)
次要结局
- Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire(Baseline, 6 and 12 months)
- Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item(Baseline, 6 and 12 months)
- Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Physical Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire(Baseline, 6 and 12 months)
- Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Functional Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire(Baseline, 6 and 12 months)
- Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire(Baseline, 6 and 12 months)
- Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire(Baseline, 6 and 12 months)
- Percentage of Participants Categorized as Improved, Stable, or Worsened in Global Health-Related Quality of Life (HRQoL) at 6 and 12 Months, Using the FACT-ES Questionnaire(Baseline, 6 and 12 months)
研究者
研究点 (2)
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