LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
研究概览
简要总结
The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥ 18 years of age;
- •Histologically confirmed Stage I-IV breast cancer;
- •ECOG Performance Status 0-3;
- •Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
- •Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
- •Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
- •Signed, IRB approved written informed consent.
排除标准
- •Presence of acute, active infection;
- •History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
- •Other co-morbid illness which would impair ability to participate in the study;
- •Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
- •Prior or current receipt of histone deacetylase (HDAC) inhibitors
结局指标
主要结局
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
时间窗: 24 months
To measure and correlate baseline p16INK4a expression in subjects with stage I-IV breast cancer starting a new course of chemotherapy with a post cycle 1 chemotherapy absolute neutrophil count (ANC).
次要结局
- Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy(24 months)
- Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function(24 months)
- Explore the Associations between p16INK4a Expression at Baseline and Other Chemotherapy-Related Toxicities including Nausea and Vomiting, Neuropathy, Fatigue and Other Grade 3 and 4 Toxicities(24 Months)