NCT04796220进行中（未招募）1 期
Focused Ultrasound With Low-Dose Gemcitabine to Augment Immune Control of Early Stage Breast Cancer
Patrick Dillon, MD2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Rate of positive margins following surgery
研究概览
简要总结
This study will test the use of focused ultrasound ablation, low-dose gemcitabine (a chemotherapy) and the combination of focused ultrasound ablation plus low-dose gemcitabine in patients with early-stage breast cancers. We will be testing the effects of each of these regimens on cells in the immune system. We hypothesize that the combination of focused ultrasound ablation and gemcitabine will decrease myeloid-derived suppressor cells and will increase T cell activity. We also hypothesize that focused ultrasound ablation and low-dose gemcitabine will be safe and will result in non-inferior surgical completion rates and tumor margin assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Disease Status
- •Patients must have histologically confirmed, newly diagnosed breast cancer, stage 1-3 disease and be appropriate surgical candidates for complete resection. Recurrent disease patients must have disease localized to the breast, chest wall or axilla and must be surgical candidates for completion resection of recurrent disease.
- •If genomic profiling is performed, then the results must indicate that the cancer is high-risk
- •Any receptor status may be eligible (estrogen receptor, progesterone receptor, HER2 receptor)
- •Patients must have a lesion in the breast/chest wall/axilla that is accessible to focused ultrasound ablation.
- •Accessible is defined as the following:
- •A targetable portion of the tumor must be ≥ 5mm from the skin
- •The rib cage should not be in the prefocal ultrasound path or behind the target area of the lesion (minimum distance from the posterior aspect of the target area to rib cage must be at least 10 mm).
- •Participants must have at least one high-risk feature of breast cancer (tumor size and nodal status may be measured by mammogram, MRI, US, CT, or calipers):
- •Triple negative breast cancer with Tumor size ≥10mm
- •Lymph node involvement by imaging or biopsy (any receptor status, any size)
- •Tumor size ≥ 20mm (estrogen receptor positive, HER2 negative)
- •Tumor size ≥ 10mm (HER2 receptor positive, any ER status)
- •Tumor size ≥ 10mm and Oncotype or Mammaprint high status (estrogen receptor positive, HER2 negative) *If patient has more than one tumor, then the treated tumor must have a high-risk feature (if 2 tumors meet high risk criteria), they may both be treated).
- •Willing and able to provide written consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, ≥ 18 years
- •Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
- •ECOG performance status of 0-2
- •Adequate organ function
- •Agreement to adhere to lifestyle considerations throughout the study duration
排除标准
- •Received other treatment (standard or investigational) for their current breast cancer.
- •Pregnant or lactating
- •Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to enrollment with the following exceptions:
- •In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function.
- •Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent).
- •Topical, nasal, and intra-articular corticosteroids are acceptable.
- •Known allergic reactions to gemcitabine
- •Breast implant on the side of the body that will receive HIFU application
- •Known history of HIV (Patients with HIV will be excluded because immunotherapy may impact the T cell profiling as part of the biologic correlates and the natural history of the disease)
- •Known active Hepatitis B virus or Hepatitis C virus
- •Other malignancy other than basal cell carcinoma of the skin or squamous cell carcinoma of the skin that is undergoing potentially curative therapy, ductal carcinoma in situ (DCIS), or in situ cervical cancer
- •Active infection requiring other systemic therapy
- •Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- •Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that precludes participation
研究组 & 干预措施
Arm B: FUS
Experimental
干预措施: Focused Ultrasound (Device)
Arm C: GEM/FUS
Experimental
干预措施: Gemcitabine and Focused Ultrasound (Other)
结局指标
主要结局
Rate of positive margins following surgery
时间窗: Day 22
Number of participants who have positive tumor margins at the time of surgery
Rate of participants experiencing a delay in surgery
时间窗: Through month 7 (Follow-up visit 2)
Rate of participants experiencing a delay in surgery, beyond day 26
Number of participants with any ≥ grade 3 adverse event
时间窗: Adverse events collected through 30 days after the last study treatment
Adverse events as measured by CTCAE v5.0
次要结局
- Patient and physician reported results on cosmesis(through month 7)
- The effect of the treatments on myeloid-derived suppressor cells (MDSC) and CD8+ T cells in the tumor microenvironment(Day 22)
- The effect of the treatments on circulating activated T cells(Measured through 30 days after the last active treatment visit)
- The effects of the treatments on dendritic cells in the tumor microenvironment(Day 22)
- Patient satisfaction with treatment regimen and surgery(through month 7)
- Residual cancer burden(Day 22)
研究者
Patrick Dillon, MD
Associate Professor, Department of Medicine
University of Virginia
研究点 (2)
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