Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)

National University Health System (NUHS)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Combination Product: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane; Device: Pulsed electromagnetic fields (PEMFs)

Study type: Interventional

Funder types: Other

Identifiers

NCT06332508

2022/00406

Details and patient eligibility

About

To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.

Full description

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.

Enrollment: 14 patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)

2. ECOG 0-1.

3. Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy

4. Adequate organ function including the following:

   1. Bone marrow:

      1. Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 10^9/L
      2. Platelets >= 100 x 10^9/L
      3. Hemoglobin >= 8 x 10^9/L

   2. Hepatic:

      1. Bilirubin <= 1.5 x upper limit of normal (ULN),
      2. ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases)

   3. Renal:

      1. Creatinine <= 1.5x ULN

5. Signed informed consent from subject or legal representative.

6. Able to comply with study-related procedures.

Exclusion criteria

1. Pregnancy.
2. Breast feeding.
3. Presence of fungating breast tumor or open wound in breast planned for PEMF.
4. Active bleeding disorder or bleeding site.
5. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
6. Major surgery within 28 days prior to study administration.
7. Non-healing wound.
8. Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
9. History of significant neurological or mental disorder, including seizures or dementia.
10. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Dose Level 1 (Metastatic Disease)

Experimental group

Description:

Patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session.

Treatment:

Device: Pulsed electromagnetic fields (PEMFs)

Device: Pulsed electromagnetic fields (PEMFs)

Dose Level 2 (Pre-Surgical)

Experimental group

Description:

Patients planned for upfront surgical resection receive a single PEMF session prior to surgery.

Treatment:

Device: Pulsed electromagnetic fields (PEMFs)

Device: Pulsed electromagnetic fields (PEMFs)

Dose Level 3 (Neoadjuvant Chemotherapy

Experimental group

Description:

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).

Treatment:

Combination Product: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane