To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
A single 30-minute PEMF session to assess local toxicity.
A single 30-minute PEMF session administered 30 minutes pre-surgery to assess wound-healing safety.
A single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy.
National University Hospital
Singapore, Singapore, Singapore
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
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
Time frame: up to 6 months
Treatment response as assessed by clinical measurement of tumor size using calipers
Subjects should have documented the size of the tumor through clinical measurement using calipers at each assessment visit. Wherever possible, documentation of radiological size based on mammogram, ultrasound or magnetic resonance imaging should also be recorded.
Time frame: up to 6 months
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