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

Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline-based chemotherapy

• Registration Number: NCT06332508
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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

Detailed Description

This is a single-center phase Ib study to investigate the safety and tolerability of the combination of PEMF with anthracycline-based chemotherapy. Subjects will be enrolled on a 3+3 dose escalation design from dose level 1 with a target to reach dose level 4, where PEMF can be administered prior to each cycle of anthracycline-based chemotherapy. In the first 2 dose levels, PEMFs will first be administered to subjects who are planned for upfront surgical resection to ensure that PEMFs is safe and tolerable for up to 0.5-hour. Once the duration of each PEMF treatment is established, PEMFs will then be added to anthracycline-based chemotherapy to investigate the safety and tolerability of the combination treatment.

Study Timeline

• Study First Submitted: 2022-10-07
• Study Start: 2022-12-30
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEMFs prior to surgery	Pulsed electromagnetic fields (PEMFs)	During the study period, subjects will receive local magnetic therapy (PEMFs). The study aims to enrol subjects in 4 groups - in dose level 1 and 2 (subjects who do not need chemotherapy prior to surgery), PEMF will be administered prior to surgery;
PEMFs prior to chemotherapy	Pulsed electromagnetic fields (PEMFs)	In dose level 3 and 4 (subjects who require chemotherapy), PEMF will be administered prior to chemotherapy.
PEMFs prior to chemotherapy	Anthracycline-based chemotherapy	In dose level 3 and 4 (subjects who require chemotherapy), PEMF will be administered prior to chemotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0	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

Secondary Outcome Measures

Name	Time	Method
Treatment response as assessed by clinical measurement of tumor size using calipers	up to 6 months	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore