Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Total adipose tissue (TAT)
研究概览
简要总结
The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib).
详细描述
The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib). There is preliminary data suggesting that these drugs have more effect on body fat mass than body muscle mass. These drugs have already been approved by U.S Food and Drug Administration (FDA) to treat ER+/HER2- metastatic breast cancer. The investigators will follow up body composition changes among patients who receive CDK 4/6 inhibitors as part of their standard of care. Body composition changes will be measured from Computed Tomography (CT) or Positron Emission Tomography/Computed Tomography (PET/CT) scans that are part of standard of care treatment, and from DEXA scans (DEXA is optional and will be performed only if available). The investigators will also conduct body measurements with measuring tape and will draw blood tests to assess for fat biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 adenocarcinoma of the breast that is Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive based on current American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines
- •Metastatic or locally advanced/inflammatory, unresectable breast cancer not amenable to potentially curative surgery
- •Measurable and/or non-measurable as defined by RECIST 1.1 criteria
- •Patients must be a candidate to start an FDA approved CDK 4/6 inhibitor (palbociclib, ribociclib, abemaciclib) as part of standard of care treatment
- •Female, or male patients, and age >=18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Ability to understand and the willingness to sign a written informed consent document
- •Concomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factor (G-CSF) is allowed as per physician decision
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK 4/6 inhibitors or other agents used in the study (e.g., fulvestrant, letrozole, anastrozole, exemestane)
- •BMI < 18.5
- •Prior CDK 4/6 use in any setting
- •Inability to undergo anthropometric measurements
- •Inability to undergo CT scan imaging
- •Women of child-bearing potential must not be pregnant or breast feeding. They must also agree to use adequate contraception (hormonal or barrier method of birth control) and not be breast feeding prior to study entry, for the duration of study participation, and for up to 10 days after completion of all protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or up to 10 days after completion of protocol therapy, she should inform her treating physician immediately
- •Intercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension)
- •Psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimen
- •Patients with untreated brain metastasis are excluded. Patients with a prior history of brain metastasis are eligible if they have received prior brain radiation (whole brain or stereotactic radiosurgery) or surgery, have stable intracranial disease for at least 3 months after completion of local therapy, and are not taking corticosteroids for treatment of brain metastasis
- •Patients who have not recovered (i.e., CTCAE Grade ≤1 or baseline) from an adverse event due to a previously administered agent, excluding alopecia
- •Patients with inability to swallow and retain pills
- •Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption
- •Patients with active implanted medical devices (cardiac pacemakers, defibrillators or patients connected to electronic life support devices)
研究组 & 干预措施
ER+/HER2- metastatic breast cancer
Subjects have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment. It is hypothesized that cyclin-dependent kinase (CDK) 4/6 inhibitors decrease fat mass among women with ER+/HER2- metastatic breast cancer without significant effect in the skeletal mass. Body composition will be obtained from CT scans (CT or PETCT) as part of standard of care, and body fat mass will be obtained from DEXA scan (DEXA will be performed only if available)
干预措施: CT scans (Diagnostic Test)
ER+/HER2- metastatic breast cancer
Subjects have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment. It is hypothesized that cyclin-dependent kinase (CDK) 4/6 inhibitors decrease fat mass among women with ER+/HER2- metastatic breast cancer without significant effect in the skeletal mass. Body composition will be obtained from CT scans (CT or PETCT) as part of standard of care, and body fat mass will be obtained from DEXA scan (DEXA will be performed only if available)
干预措施: DEXA scan (Diagnostic Test)
结局指标
主要结局
Change in Total adipose tissue (TAT)
时间窗: From Baseline and 6 months after CDK 4/6 inhibitor therapy
Total Adipose tissue (TAT) is defined as the sum of intramuscular adipose tissue (IMAT), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) obtained from L3 cross section from CT scans. Only patients who complete 24 weeks of CDK 4/6 inhibitor treatment and have no radiological/clinical signs of disease progression will be included in the analysis of primary endpoint. Results will be calculated and summarized in area (cm²).
次要结局
- Adipose Serum Biomarkers - Fasting Glucose(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - Lipid Panel (Total Cholesterol and LDL cholesterol, HDL cholesterol, and Triglycerides)(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - Dehydroepiandrosterone Sulphate (DHEAS)(Baseline and 3 months and 6 months after CDK 4/6 therapy)
- Adipose Serum Biomarkers - Insulin(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - Leptin(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - Free Leptin Index (FLI)(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - Adiponectin(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Adipose Serum Biomarkers - High-sensitivity C-reactive protein (hsCRP)(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy)
- Body Fat Mass (BFM) using Bioimpedance spectroscopy (BIS)(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy, and every 3 months thereafter up to 24 months)
- Body Fat-Free Mass (FFM)(Baseline and 3 months and 6 months after CDK 4/6 inhibitor therapy, and every 3 months thereafter up to 24 months)
- Anthropometric measurements - Body Mass Index (BMI)(Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months)
- Anthropometric measurements - Skin fold thickness (biceps, triceps, subscapular, and suprailiac)(Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months)
- Anthropometric measurements - Abdominal circumference(Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months)
- Anthropometric measurements - Waist-to-hip ratio(Baseline and every 4 weeks for the first 6 months after CDK 4/6 inhibitor therapy and every 3 months thereafter up to 24 months)
- Body Fat Mass (BFM) using Dual-energy X-ray Absorptiometry (DEXA)(Baseline and 6 months after CDK 4/6 inhibitor therapy)
- Body Lean Mass (BLM) using Dual-energy X-ray Absorptiometry (DEXA)(Baseline and 6 months after CDK 4/6 inhibitor therapy)
- Skeletal muscle index (SMI)(Baseline and 6 months after CDK 4/6 inhibitor therapy)