Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), First-in-man Phase 1 Safety Trials
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
研究概览
简要总结
To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.
详细描述
This was a single-center, open-label, Phase Ib study utilizing a 3+3 dose-escalation design. Patients with histologically confirmed ductal carcinoma were enrolled into three sequential cohorts. Dose Level 1 (DL1) enrolled patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) for a single 30-minute PEMF session to assess local toxicity. Dose Level 2 (DL2) enrolled patients were planned for upfront surgical resection (Grade 1-2, ER+/PR+) to assess wound-healing safety; PEMF was administered 30 minutes pre-surgery. Dose Level 3 (DL3) enrolled patients undergoing neoadjuvant chemotherapy (Grade 3, Stage I-III) to receive PEMF 30 minutes prior to their final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy. The primary endpoints were safety and incidence of device-related adverse events. The trial ended at Dose Level 3 and demonstrates that a 30-minute PEMF application is safe and well-tolerated in breast cancer patients across metastatic, pre-surgical, and neoadjuvant chemotherapy settings. The intervention had no adverse effect on surgical wound healing or on chemotherapy administration. These findings support the closure of the Phase I safety evaluation and justify progression to a Phase II trial to evaluate the efficacy of PEMF in enhancing chemotherapeutic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
- •Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy
- •Adequate organ function including the following:
- •Bone marrow:
- •Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 10^9/L
- •Platelets >= 100 x 10^9/L
- •Hemoglobin >= 8 x 10^9/L
- •Bilirubin <= 1.5 x upper limit of normal (ULN),
- •ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases)
- •Creatinine <= 1.5x ULN
- •Signed informed consent from subject or legal representative.
- •Able to comply with study-related procedures.
排除标准
- •Breast feeding.
- •Presence of fungating breast tumor or open wound in breast planned for PEMF.
- •Active bleeding disorder or bleeding site.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Major surgery within 28 days prior to study administration.
- •Non-healing wound.
- •Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
- •History of significant neurological or mental disorder, including seizures or dementia.
- •Serious concomitant disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.
研究组 & 干预措施
Dose Level 1 (Metastatic Disease)
Patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session.
干预措施: Pulsed electromagnetic fields (PEMFs) (Device)
Dose Level 2 (Pre-Surgical)
Patients planned for upfront surgical resection receive a single PEMF session prior to surgery.
干预措施: Pulsed electromagnetic fields (PEMFs) (Device)
Dose Level 3 (Neoadjuvant Chemotherapy
Patients undergoing neoadjuvant chemotherapy receive a single PEMF session prior to their final chemotherapy cycle. This cohort is subdivided into those receiving Anthracycline (DL3a) and those receiving Taxane (DL3b).
干预措施: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane (Combination Product)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
时间窗: up to 6 months
Toxicity to treatment as assessed by Common Terminology Criteria for Adverse Events 5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe. A dose limiting toxicity will be defined as Grade 3 or above toxicity of the following: a) pain in breast where PEMF was applied * Increased intra-operatively bleeding whereby surgical bed require a longer period of hemostases * Post-surgical complications including delay wound healing (open wound of more than 5 days post-surgery), wound infection and wound dehiscence, hematoma formation
次要结局
- Treatment response as assessed by clinical measurement of tumor size using calipers(up to 6 months)