NCT07257484招募中4 期
Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of participants completing week 24 visit with all required assessments
研究概览
简要总结
This study will explore whether tirzepatide is a practical and acceptable treatment for postmenopausal females with a history of hormone receptor-positive breast cancer and obesity. The investigators aim to understand whether participants are willing and able to take this medication once weekly for 6 months and whether it may help improve weight and overall health. There will be monthly check-ins to monitor progress and safety. At the beginning and end of the study, participants will undergo body composition assessments, blood tests and a stool sample will be collected, and surveys will be completed.
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
- •Biologically female
- •Obesity as defined by current BMI ≥ 30 kg/m² or ≥ 27.5 kg/m² for individuals of Asian ancestry
- •Postmenopausal as defined by one or more of the following
- •Age ≥60 years
- •Age <60 years with amenorrhea for ≥ 1 year
- •Documented bilateral surgical oophorectomy
- •Chemical menopause with the addition of LHRH agonists at least 12 weeks prior to enrolment, and plan to remain on LHRH agonists throughout the trial
- •HR+ (ER and/or PR) stage 0-III breast cancer
- •Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
- •Insurance approval for tirzepatide or willing to pay out of pocket
- •Willing to provide informed consent and comply with study procedures
排除标准
- •Stage IV breast cancer
- •Concomitant use of CDK inhibitors
- •Concomitant use of antiHER2 therapy
- •The PI may be consulted regarding enrollment of females receiving other endocrine therapy medications
- •Other active malignancy requiring treatment
- •Enrollment in another investigational clinical trial
- •Contraindication to tirzepatide
- •Treatment with a GLP-1 receptor agonist within the last 3 months
- •Diabetes requiring insulin
- •Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
研究组 & 干预措施
Drug
Experimental
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percentage of participants completing week 24 visit with all required assessments
时间窗: 24 weeks
次要结局
- Percent change in body weight from baseline to week 24(Baseline, 24 weeks)
- Absolute change in visceral fat mass from baseline to week 24(Baseline, 24 weeks)
- Percent change in visceral fat mass from baseline to week 24(Baseline, 24 weeks)
- Absolute change in fasting glucose from baseline to week 24(Baseline, 24 weeks)
- Percent change in fasting glucose from baseline to week 24(Baseline, 24 weeks)
- Absolute change in fasting insulin from baseline to week 24(Baseline, 24 weeks)
- Percent change in fasting insulin from baseline to week 24(Baseline, 24 weeks)
- Absolute change in hemoglobin A1c from baseline to week 24(Baseline, 24 weeks)
- Percent change in hemoglobin A1c from baseline to week 24(Baseline, 24 weeks)
- Absolute change in IGF-1 from baseline to week 24(Baseline, 24 weeks)
- Percent change in IGF-1 from baseline to week 24(Baseline, 24 weeks)
- Absolute change in leptin from baseline to week 24(Baseline, 24 weeks)
- Percent change in leptin from baseline to week 24(Baseline, 24 weeks)
- Absolute change in adiponectin from baseline to week 24(Baseline, 24 weeks)
- Percent change in adiponectin from baseline to week 24(Baseline, 24 weeks)
- Absolute change in hs-CRP from baseline to week 24(Baseline, 24 weeks)
- Percent change in hs-CRP from baseline to week 24(Baseline, 24 weeks)
- Absolute change in ghrelin from baseline to week 24(Baseline, 24 weeks)
- Percent change in ghrelin from baseline to week 24(Baseline, 24 weeks)
研究者
研究点 (1)
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