Effect of Physical Exercise on Ki-67 Levels in Women With Operable Breast Cancer Hormonal Receptor Positive, HER2 Negative
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proliferation Score
研究概览
简要总结
Observational study to evaluate the effect of physical exercise prior to surgery and adjuvant systemic treatment in women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers
详细描述
Effect of exercise on tumor aggressiveness and the impact on patients' quality of life.
Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, previously untreated clinical stage I-IIIA without previous treatment.
- •ER positive breast cancer according to local results. (RH+ is defined as ≥ 1% assessed by Immunohistochemistry (IHC) to Estrogen Receptor (ER) and/or Progesterone Receptor (P)E).
- •HER2 negative in the primary tumour according to local results. (HER2 confirmation should be done following the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines)
- •Scheduled to undergo surgical resection.
- •Ki67 levels must be over 13%, according to local results.
- •At least 14 days from enrolment to planned surgical resection.
- •Karnofsky performance status of at least 70% at study entry or 0-1 level in Eastern Cooperative Oncology Group (ECOG) Scale.
- •Signed consent prior to initiation of study-related procedures.
排除标准
- •Schedule to receive any form of induction/neoadjuvant therapy
- •Significant cardiac disease (ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within precious 6 months)
- •Any pulmonary dysfunction which may affect to the exercise program perform.
- •Any mental disease or condition that compromise the physical, psychological and emotional patients' wellness or affect to the process.
- •Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society.
结局指标
主要结局
Proliferation Score
时间窗: Post-surgery, an average of 6 months
A 50-gene quantitative polymerase chain reaction (qPCR) assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.
Tumor proliferation (Ki67)
时间窗: Post-surgery, an average of 6 months
Tumor proliferation (Ki67) will be assessed immunohistochemically at basal biopsies versus post-surgery tumor samples.
次要结局
- Change from baseline molecular subtypes(Post-surgery, an average of 6 months)
- Change in body composition(Post-surgery, an average of 6 months)
- Changes in tumor microenvironment: levels of factor Hypoxia-inducible factor 1 (HIF-1)(Post-surgery, an average of 6 months)
- Change in tumor microenvironment: levels of cleaved caspase 3(Post-surgery, an average of 6 months)
- Change in quality of life levels(Post-surgery, an average of 6 months)
- Changes in tumor microenvironment: levels of Vascular endothelial growth factor (VEGF)(Post-surgery, an average of 6 months)
- Oxygen uptake during peak exercise (VO2peak)(Post-surgery, an average of 6 months)
- Change in depression levels(Post-surgery, an average of 6 months)
- Change in fatigue levels(Post-surgery, an average of 6 months)