Does Ablation (Cryoablation or Histotripsy) Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Change in CD4-PD1 from baseline to post-cryoablation
研究概览
简要总结
Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with ablation (cryoablation or histotripsy) OR pembrolizumab alone. Participants will be randomly assigned.
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
- •Patients ≥ 18 years of age
- •Confirmed histologic diagnosis of metastatic TNBC or locally advanced inoperable TNBC
- •1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.
- •Physically fit (clinically eligible) to undergo ablation as per usual clinical practice
- •Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to ablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before ablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").
- •Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy
- •Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and ablation is not restricted):
- •Capecitabine (Xeloda, available as a generic drug)
- •Carboplatin (Paraplatin, available as a generic drug)
- •Cisplatin (Platinol, available as a generic drug)
- •Cyclophosphamide (Cytoxan, available as a generic drug)
- •Docetaxel (Taxotere)
- •Doxorubicin (Adriamycin, available as a generic drug)
- •Pegylated liposomal doxorubicin (Doxil)
- •Epirubicin (Ellence, available as a generic drug)
- •Eribulin (Halaven)
- •Fluorouracil (5-FU, Adrucil, available as a generic drug)
- •Gemcitabine (Gemzar, available as a generic drug)
- •Ixabepilone (Ixempra)
- •Methotrexate (available as a general drug)
- •Nab-paclitaxel (Abraxane)
- •Paclitaxel (Taxol, available as a generic drug)
- •Vinorelbine (Navelbine, available as a generic drug)
排除标准
- •Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
- •No disease amenable for ablation
- •Pembrolizumab therapy not planned as part of standard of care
研究组 & 干预措施
Pembrolizumab + Ablation (Cryoablation or Histotripsy)
Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
干预措施: Cryoablation (Device)
Pembrolizumab + Ablation (Cryoablation or Histotripsy)
Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
干预措施: Histotripsy (Device)
Pembrolizumab + Ablation (Cryoablation or Histotripsy)
Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
干预措施: Pembrolizumab (Drug)
Pembrolizumab
Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Change in CD4-PD1 from baseline to post-cryoablation
时间窗: 6 weeks after cryoablation
Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).
Change in CD4-PD1 from baseline to post-ablation
时间窗: 6 weeks after cryoablation
Assess changes in CD4-PD1 in the blood after ablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).
次要结局
未报告次要终点