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

National University Health System (NUHS)

Status and phase: Enrolling; Phase 1

Conditions: Breast Cancer

Treatments: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline-based chemotherapy

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 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.

Enrollment: 36 estimated 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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36 participants in 2 patient groups

PEMFs prior to surgery

Experimental group

Description:

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;

Treatment:

Device: Pulsed electromagnetic fields (PEMFs)

PEMFs prior to chemotherapy

Experimental group

Description:

In dose level 3 and 4 (subjects who require chemotherapy), PEMF will be administered prior to chemotherapy.

Treatment:

Drug: Anthracycline-based chemotherapy

Device: Pulsed electromagnetic fields (PEMFs)