Overview
To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.
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
Inclusion Criteria:
- Histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
- ECOG 0-1.
- Non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy
- Adequate organ function including the following:
- Bone marrow:
- Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Hemoglobin >= 8 x 10^9/L
- Hepatic:
- Bilirubin <= 1.5 x upper limit of normal (ULN),
- ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases)
- Renal:
- Creatinine <= 1.5x ULN
- Bone marrow:
- Signed informed consent from subject or legal representative.
- Able to comply with study-related procedures.
Exclusion Criteria:
- Pregnancy.
- Breast feeding.
- Presence of fungating breast tumor or open wound in breast planned for PEMF.
- Active bleeding disorder or bleeding site.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Major surgery within 28 days prior to study administration.
- Non-healing wound.
- Active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy.
- History of significant neurological or mental disorder, including seizures or dementia.
- 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.