Breast Cancer
Conditions
Keywords
Pulsed Electromagnetic Fields (PEMFs)
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 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.
Interventions
DEVICEPulsed electromagnetic fields (PEMFs)
A single 30-minute PEMF session to assess local toxicity.
COMBINATION_PRODUCTDevice: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane
A single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy.
Sponsors
National University Hospital, Singapore
National University of Singapore
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORRachel Wong, Medical Degree
National University Hospital, Singapore
Outcome results
None listed