Clinical trial NCT06332508: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)
Official title: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), First-in-man Phase 1 Safety Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Pulsed Electromagnetic Fields (PEMFs)
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2024-03-27
Enrollment: 36
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
timeFrame: up to 6 months
Secondary outcomes:
measure: Treatment response as assessed by clinical measurement of tumor size using calipers
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Si Jing, Joline Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tai YK, Chan KKW, Fong CHH, Ramanan S, Yap JLY, Yin JN, Yip YS, Tan WR, Koh APF, Tan NS, Chan CW, Huang RYJ, Li JZ, Frohlich J, Franco-Obregon A. Modulated TRPC1 Expression Predicts Sensitivity of Breast Cancer to Doxorubicin and Magnetic Field Therapy: Segue Towards a Precision Medicine Approach. Front Oncol. 2022 Jan 24;11:783803. doi: 10.3389/fonc.2021.783803. eCollection 2021.
citation: Haidinger R, Bauerfeind I. Long-Term Side Effects of Adjuvant Therapy in Primary Breast Cancer Patients: Results of a Web-Based Survey. Breast Care (Basel). 2019 Apr;14(2):111-116. doi: 10.1159/000497233. Epub 2019 Feb 15.