Breast CancerPhase 1NCT06332508
Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL)
A Phase 1 study testing Pulsed electromagnetic fields (PEMFs) and Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane in people with Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pulsed electromagnetic fields (PEMFs) and Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Dec 2022to 8 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Signed informed consent from subject or legal representative.
- Able to comply with study-related procedures.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), First-in-man Phase 1 Safety Trials
To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Pulsed electromagnetic fields (PEMFs), Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane
- Keywords
- Pulsed Electromagnetic Fields (PEMFs)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fields (PEMFs)Device
A single 30-minute PEMF session to assess local toxicity.
Pulsed electromagnetic fields (PEMFs)Device
A single 30-minute PEMF session administered 30 minutes pre-surgery to assess wound-healing safety.
Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR TaxaneCombination product
A single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (Metastatic Disease) | Experimental | Patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session. Receives: Device: Pulsed electromagnetic fields (PEMFs) |
| Dose Level 2 (Pre-Surgical) | Experimental | Patients planned for upfront surgical resection receive a single PEMF session prior to surgery. Receives: Device: Pulsed electromagnetic fields (PEMFs) |
| Dose Level 3 (Neoadjuvant Chemotherapy | Experimental | Patients undergoing neoadjuvant chemotherapy receive a single PEMF session prior to their final chemotherapy cycle. This cohort is subdivided into those receiving Anthracycline (DL3a) and those receiving Taxane (DL3b). Receives: Combination Product: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
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:
- 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
Measured: up to 6 months
Secondary outcomes (1)
Treatment response as assessed by clinical measurement of tumor size using calipers
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start30 Dec 2022
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Rachel Wong, Medical Degree, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332508
- Sponsor's protocol ID
- 2022/00406
- Status last verified
- Aug 2025
- First submitted
- 7 Oct 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35141145Haidinger 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.
PubMed 31798383
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), First-in-man Phase 1 Safety Trials
- ClinicalTrials.gov ID
- NCT06332508
- Acronym / sponsor ID
- 2022/00406
- Conditions
- Breast Cancer
- Keywords
- Pulsed Electromagnetic Fields (PEMFs)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (Metastatic Disease) | Experimental | Device: Pulsed electromagnetic fields (PEMFs)Patients with metastatic disease (Grade 3, Stage III/IV, ER-/HER2+) receive a single PEMF session. |
| Dose Level 2 (Pre-Surgical) | Experimental | Device: Pulsed electromagnetic fields (PEMFs)Patients planned for upfront surgical resection receive a single PEMF session prior to surgery. |
| Dose Level 3 (Neoadjuvant Chemotherapy | Experimental | Combination Product: Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR TaxanePatients undergoing neoadjuvant chemotherapy receive a single PEMF session prior to their final chemotherapy cycle. This cohort is subdivided into those receiving Anthracycline (DL3a) and those receiving Taxane (DL3b). |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Signed informed consent from subject or legal representative.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electromagnetic fields (PEMFs)A single 30-minute PEMF session to assess local toxicity. | Device | Dose Level 1 (Metastatic Disease) |
| Pulsed electromagnetic fields (PEMFs)A single 30-minute PEMF session administered 30 minutes pre-surgery to assess wound-healing safety. | Device | Dose Level 2 (Pre-Surgical) |
| Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR TaxaneA single 30-minute PEMF session administered 30 minutes prior to the final cycle (4th cycle) of either Anthracycline (DL3a) or Taxane (DL3b) therapy. | Combination product | Dose Level 3 (Neoadjuvant Chemotherapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Time frame: 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
1 secondary outcome
Treatment response as assessed by clinical measurement of tumor size using calipers
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 35141145Tai 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.
- Background: PubMed 31798383Haidinger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Wong, Medical Degree principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pulsed electromagnetic fields (PEMFs) and Device: Pulsed electromagnetic fields (PEMFs); Drug: Anthracycline OR Taxane in people with Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.