Prospective Evaluation of the Gut Microbiome and a Pilot Dietary Intervention in Patients With HR+/HER2- Breast Cancer Receiving Abemaciclib (GEMMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stool Sampling Feasibility
研究概览
简要总结
This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds). The study aims to evaluate the relationship between the gut microbiome (a diverse ecosystem of microorganisms that affects your health and well-being) and treatment-related gastrointestinal toxicities in patients with HR+/HER2- breast cancer receiving abemaciclib plus endocrine therapy.
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 序贯
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
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
- Be willing and able to provide written informed consent for the trial
- Be a male or female subject 18 years of age on day of signing informed consent.
- Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:
- HER2 negative in primary tumour pre-treatment by local pathology assessed according current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.
- Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as >1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
- Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2).
- Be willing to provide mandatory stool samples at baseline and on treatment.
- The Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- Patients who are pregnant or breast-feeding
- Current use of any investigational agents
- Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
研究组 & 干预措施
Dietary Intervention Cohort
Enrolled patients with early-stage HR+/HER2- breast cancer. A 2-week chia seed intervention will be administered prior to initiation of abemaciclib. The goal of this high fiber intervention is to favorably modulate the gut microbiome by supporting a more diverse microbiome and reducing the risk of inflammation and dysbiosis.
干预措施: Chia Seeds (Other)
Observational Cohort
Enrolled patients with early or advanced HR+/HER2- breast cancer starting abemaciclib as per standard of care to characterize the baseline composition and longitudinal dynamics of the gut microbiome before and during treatment. Stool samples will be collected continuously using the GutLab platform, alongside clinical toxicity assessments, with a focus on identifying microbial signatures associated with the development and severity of diarrhea. No intervention will be administered.
干预措施: Stool Sampling (Other)
Dietary Intervention Cohort
Enrolled patients with early-stage HR+/HER2- breast cancer. A 2-week chia seed intervention will be administered prior to initiation of abemaciclib. The goal of this high fiber intervention is to favorably modulate the gut microbiome by supporting a more diverse microbiome and reducing the risk of inflammation and dysbiosis.
干预措施: Stool Sampling (Other)
结局指标
主要结局
Stool Sampling Feasibility
时间窗: 2 years
Proportion of enrolled participants who provide serial stool samples during the baseline and on-treatment periods, as recorded by device data and study records.
次要结局
- Baseline Microbiome-Diarrhea Associations(2 years)
- Microbiome Dynamics and Diarrhea(2 years)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07553234
- 其他研究编号
- IRB25-2098
日期
- 首次提交
- (7个月前)
- 首次发布
- (5个月前)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否