Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (WE-FiERCE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 71
- 主要终点
- Assessment of Complete Pathologic Response
研究概览
简要总结
The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.
详细描述
The research aims to answer the question: "Does the addition of a Glucose-dependent Insulinotropic Polypeptide (GIP)/Glucagon-like Peptide-1 (GLP-1) co-agonist to standard progestin treatment lead to a higher complete response rate compared to historical response rates using progestin alone in young patients with endometrial cancer/atypical hyperplasia who wish to preserve their fertility?".
This is a multicentre single arm open-label phase II clinical trial to assess the complete pathologic response as determined by endometrial sampling after 48 weeks of tirzepatide (GIP/GLP-1 co-agonist) and progestin therapy in patients with BMI ≥ 27 who have endometrial cancer/atypical hyperplasia and desire fertility preservation.
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 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of grade 1 or 2 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage
- •For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT
- •ECOG status <2
- •Desire for fertility preservation
- •Ability to understand and willing to sign a written informed consent document
排除标准
- •Evidence of myometrial invasion or extra-uterine disease on imaging
- •High grade or p53 mutated (p53mut) endometrial cancer
- •Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining>10%)
- •Mismatch repair deficient (MMRd) endometrial cancer
- •History of other malignancies except if curatively treated with no evidence of disease for >5 years
- •Previous surgical treatment of obesity
- •Current use of weight loss medication (no use in last 2 months)
- •Medical co-morbidity with end-organ dysfunction
- •Contraindications to pIUD or tirzepatide.
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
研究组 & 干预措施
Tirzepatide and Progestin Intrauterine Device
All patients will receive a progestin intrauterine device and tirzepatide subcutaneous injections
干预措施: Mounjaro (Drug)
Tirzepatide and Progestin Intrauterine Device
All patients will receive a progestin intrauterine device and tirzepatide subcutaneous injections
干预措施: Mirena (Drug)
结局指标
主要结局
Assessment of Complete Pathologic Response
时间窗: 48 weeks
Proportion of patients (%) who achieve pathological complete response at 48 weeks after initiation of pIUD and tirzepatide.
次要结局
- Assessment of Safety and Tolerability(48 weeks)
- Assessment of Feasibility(2.5 years)
- Assessment of Secondary Oncologic Outcomes(6 years)
- Assessment of Reproductive Outcomes(6 years)
- Assessment of Patient Reported Outcomes(48 weeks)
- Assessment of Metabolic Outcomes(48 weeks)