Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer (ENHANCE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Association of peripheral blood immune phenotypes with pathological complete response
研究概览
简要总结
This early phase I trial evaluates the impact of chemotherapy before surgery (neoadjuvant) on the peripheral blood immune phenotype in patients with operable breast cancer. Collecting blood and information from patients with breast cancer may help to understand how the immune system influences response to treatment, and how the immune system reacts to breast cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate whether pre-neoadjuvant chemotherapy (NAC) peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer.
II. To evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.
SECONDARY OBJECTIVES:
I. To characterize changes in the baseline peripheral blood immune phenotype that arise as a consequence of neoadjuvant chemotherapy.
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
- •Age >= 18 years
- •Histologically confirmed, operable, invasive breast cancer. Note: Patients with oligometastatic breast cancer (up to 3 isolated distant metastases) will be eligible after review and approval by principal investigator (PI)
- •Recommended to receive neoadjuvant systemic treatment by their primary medical oncologist and planning to receive one of the regimens
- •Provide written informed consent
- •Willing to return to Mayo Clinic for breast cancer surgery
- •Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic
排除标准
- •Patients who have already initiated neoadjuvant chemotherapy for the current malignancy
- •Inability to provide blood samples based on the judgement of the treating physician
- •Inability to comply with the protocol
- •Patient is pregnant or plans to become pregnant
研究组 & 干预措施
Basic science (biospecimen collection)
Patients undergo blood sample collection at baseline (prior to first NAC treatment), after taxane and prior to first dose of A/C (for patients receiving a taxane), end of NAC, 1-4 weeks and 6 months post-surgery. Patients also undergo tissue collection at 1-4 weeks and 6 months post-surgery.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Association of peripheral blood immune phenotypes with pathological complete response
时间窗: Up to 5 years
For each of the ten unique family subtypes, and individual cell population within a histological subtype, will utilize a logistic regression model to identify those markers measured at baseline that are predictive of achieving a pathological complete response. Will also perform classification and regression trees (CART) modeling to get at the interplay of the markers (i.e. cell subtypes), which are all uniformly expressed as percentages.
Difference of peripheral blood immune phenotypes
时间窗: Up to 5 years
Will be assessed between patients with breast cancer and age-matched healthy controls. Will compare the average difference in the baseline marker expression between the cases and age-matched healthy controls using a two-sample t-test. The two-sample t-test will be used to test the null hypothesis of no difference in means against the alternative hypothesis that there is a difference in means; the two-sided P-value will be reported. Will also perform CART modeling as in the first co-primary objective to get at the interplay of the markers.
次要结局
- Changes in baseline peripheral blood immune phenotype as a consequence of neoadjuvant chemotherapy (NAC)(Baseline up to 2-4 weeks post-surgery)