2026-525820-76-00招募中2 期
Clinical Study of Local and Systemic biological Impact of GLP1/GIP-Receptor Agonists in patients with Breast Cancer: The CLARA trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- The primary endpoint is the mean change in log-transformed KI67 expression values between baseline and time of surgery in the different arms.
研究概览
简要总结
To compare anti-proliferative tumor response in patients receiving immediate surgery, GLP1/GIP RA, letrozole and combined treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is postmenopausal, as defined per local practice
- •Tumor size of ≥1 cm
- •The patient has a biopsy-confirmed diagnosis of GII-III ER+, HER2 – early stage breast cancer scheduled for primary surgery as per standard-of-care a. To fulfill the requirement for HR+ disease by local testing on primary disease specimen, tumor must be ER positive defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al, Arch. Pathol. Lab. 2020) . b. To fulfill the requirement of HER2- disease by local testing on primary disease specimen, tumor must be HER2- according to ASCO/CAP guidelines for HER2 testing (Wolff et al, Arch. Pathol. Lab. 2018) c. All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (IBC-NST) , invasive lobular carcinoma (ILC) etc
- •Have a BMI of a. ≥30 kg/m2 or b. ≥27 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities: i. Hypertension: treated or with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg ii. Dyslipidemia: treated or with LDL ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or HDL iii. Obstructive sleep apnea iv. Cardiovascular disease, for example, ischemic cardiovascular disease, New York Heart Association Functional Classification Class I-III heart failure
- •Patient should be able to read/understand Dutch, French or English
- •Willing to commit to the study program and comply with all related protocol procedures
- •Willing to undergo a new biopsy of the breast lesion in case no formalin-fixed paraffin-embedded (FFPE) block can be made available for the trial
排除标准
- •Has Type 1 or 2 diabetes mellitus, history of ketoacidosis, or hyperosmolar state or coma
- •Have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (Examples: mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner)
- •Have renal impairment measured as eGFR <30L/min/1.73m2
- •Have a known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility
- •Have a history of chronic or acute pancreatitis
- •Is treated with insulin or other hypoglycemic drugs (such as – but not limited to – metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors)
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device in the neoadjuvant setting
- •Have obesity induced by other endocrinologic disorders, for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity, for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome…
- •Has acute or chronic hepatitis, signs and symptoms of any other liver disease other than NAFLD, or any of the following, as determined by the central laboratory during screening: a. Alanine aminotransferase (ALT) level >3.0x ULN for the reference range b. Alkaline phosphatase (ALP) level >2.0x ULN for the reference range, or c. Total bilirubin level >1.5x ULN for the reference range (except for cases of known Gilbert’s Syndrome) Note: Participants with non-alcoholic fatty liver disease (NAFLD) are eligible to participate in this trial if their ALT level is ≤3.0x ULN for the reference range
- •Has used systemic hormonal substitution therapy within 2 months before screening
- •Has used a GLP1/(GIP)/(GC) Receptor Agonist within 2 months of screening
- •Has at least 1 laboratory value suggestive of diabetes during screening : HbA1c ≥6.5% (≥48 mmol/mol) or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
- •Has used medications (prescribed or over-the-counter) within 2 months prior to screening that promote weight loss. For example, but not limited to: a. liraglutide, orlistat, sibutramine, phenylpropanolamine, mazindol, phentermine, lorcaserin, phendimetrazine, phentermine/topiramate, naltrexone/bupropion, semaglutide, oral superabsorbent hydrogel,...
- •Has a history of BC exceptions are made for: a. Contralateral in situ BC without systemic treatment b. Ipsilateral in situ BC without systemic treatment or radiation therapy
- •Has a history of an additional invasive malignancy that is progressing or that has required active treatment in the 3 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- •Is receiving or has received within 3 months prior to screening chronic (>2 weeks or >14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or has evidence of a significant, active autoimmune that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic treatment (such as glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations)) during the course of the study.
- •Have a history of any other condition, such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
- •Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have a self-reported change in body weight >5 kg within 3 months prior to screening
- •Have a prior surgical treatment for obesity, excluding liposuction or abdominoplasty
结局指标
主要结局
The primary endpoint is the mean change in log-transformed KI67 expression values between baseline and time of surgery in the different arms.
The primary endpoint is the mean change in log-transformed KI67 expression values between baseline and time of surgery in the different arms.
次要结局
- Adherence to GLP1/GIP RA and letrozole treatment
- The type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v6.0), seriousness, time till onset and duration of Adverse Events (AEs)/SAEs and any laboratory abnormalities.
- Perioperative complications graded using the Clavien Dindo Classification (Dindo et al, 2004, Ann Surg) up till 3 weeks postoperative.
- To evaluate the presence of circulating tumor DNA (ctDNA) at baseline, during treatment and at surgery in plasma samples. To evaluate changes between baseline, during treatment and at surgery in plasma samples
研究者
Prof. Christine Desmedt
Scientific
UZ Leuven
研究点 (1)
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