Breast Cancer Stage INCT07218432
A Study of the TheraBionic P1 Device in Breast Cancer
A study testing TheraBionic P1 Device in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Barbara Ann Karmanos Cancer Institute at 8 sites in United States.
Trial summary
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA
- What is being tested?
- TheraBionic P1 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]).
- Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.
- Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection
- Participant must have archival tissue available.
- Participant must be a woman aged 22 years or older
- Participant must be able to understand a written informed consent document and be willing to sign it
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session
Who cannot join
- Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
- Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints
- Participants that are taking any other investigational drugs
- Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
- Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).
- Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.
- Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device
- Participants with a known severe (e.g., anaphylactic) allergy to nickel.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
248-922-6650
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Lubina Arjyal, MD, 1-800-527-6266, arjyall@karmanos.org
- Recruiting
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
1-800-527-6266
- Recruiting
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
810-342-3800
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
517-975-9500
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48466
810-667-4994
- Recruiting
Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, 49770
231-487-3390
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
810-982-5200
About this study
Official title: A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Being tested
- TheraBionic P1 Device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBionic P1 DeviceDevice
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| TheraBionic P1 device | Experimental | Self Administered Amplitude-modulated electromagnetic fields three times daily Receives: Device: TheraBionic P1 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response to Treatment
Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method
Measured: At time of surgery (after approximately 2 weeks of treatment and tumor resection)
Secondary outcomes (6)
Changes in microRNA expression in tumor tissue
Changes in microRNA expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Measured: Baseline to post-surgical resection
Changes in Ki-67 expression in tumor tissue
Changes in Ki-67 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Measured: Baseline to post-surgical resection
Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue
Changes in CC3 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Measured: Baseline to post-surgical resection
Changes in cell cycle arrest marker p27 in tumor tissue
Changes in p27 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Measured: Baseline to post-surgical resection
Overall survival (OS)
OS will be graphically summarized using Kaplan-Meier (KM) curves, with corresponding medians and two-sided 95% CIs computed using KM estimates. Additionally, OS rates at every six months post-treatment will be estimated using the KM estimated, with two-sided 95% CIs provided for each time point.
Measured: Up to 5 years post-surgery
Progression Free Survival (PFS)
PFS will be graphically summarized using Kaplan-Meier (KM) curves, with corresponding medians and two-sided 95% CIs computed using KM estimates. Additionally, PFS rates at every six months post-treatment will be estimated using the KM estimated, with two-sided 95% CIs provided for each time point.
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study startOct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lubina Arjyal MD, Barbara Ann Karmanos Cancer Institute
- Investigators
- Lubina Arjyal, M.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218432
- Sponsor's protocol ID
- 2025-026
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
- ClinicalTrials.gov ID
- NCT07218432
- Acronym / sponsor ID
- 2025-026
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Oct 2025 (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.
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraBionic P1 device | Experimental | Device: TheraBionic P1 DeviceSelf Administered Amplitude-modulated electromagnetic fields three times daily |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]).
- Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.
- Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection
- Participant must have archival tissue available.
- Participant must be a woman aged 22 years or older
Key exclusion criteria (8 listed)
- Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
- Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints
- Participants that are taking any other investigational drugs
- Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
- Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).
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 |
|---|---|---|
| TheraBionic P1 DeviceAmplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer. | Device | TheraBionic P1 device |
Primary outcome
Pathological Response to Treatment
Time frame: At time of surgery (after approximately 2 weeks of treatment and tumor resection)
Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method
6 secondary outcomes
Changes in microRNA expression in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in Ki-67 expression in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in cell cycle arrest marker p27 in tumor tissue
Time frame: Baseline to post-surgical resection
Overall survival (OS)
Time frame: Up to 5 years post-surgery
Progression Free Survival (PFS)
Time frame: Up to 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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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.
Lubina Arjyal, M.D. principal investigator
Wayne State University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraBionic P1 Device in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Barbara Ann Karmanos Cancer Institute at 8 sites in United States.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lubina Arjyal, M.D. (1-800-karmanos, arjyall@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Response to Treatment (time frame: At time of surgery (after approximately 2 weeks of treatment and tumor resection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.