HER2-negative Breast CancerNCT07227831
A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer
A study testing TheraBionic P1 in people with HER2-negative Breast Cancer and Hormone Receptor Positive Tumor, 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 the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer
- What is being tested?
- TheraBionic P1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Jan 2026to 22 May 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have locally advanced/unresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (estrogen receptor [ER] and/or progesterone receptor [PR] >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]).
- Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one line of endocrine + CDK4/6 inhibitor therapy AND one line of cytotoxic such as chemotherapy and/or antibody drug conjugates (ADCs).
- Participant must be a woman ≥ 22 years old and must be able to understand and sign an informed consent form.
- Participant must have a life expectancy of at least 3 months.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score 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 childbearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session.
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- Participants must meet one of the following:
- Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
- Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation.
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence methods such as calendar, ovulation, symptothermal, or post ovulation tracking are not acceptable.
- Not in a sexual relationship in which they may become pregnant (i.e. same-sex relationship)
- If they are of childbearing potential, agree to use at least one method of contraception. Withdrawal is not an acceptable contraceptive method.
Who cannot join
- 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. 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 Bay Region
Bay City, Michigan, 48706
989-667-2370
- Recruiting
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
248-922-6650
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Hadeel Assad, MD, 18005276266
- Recruiting
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
1-810-342-3800
- Recruiting
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48446
1-810-667-4994
- Recruiting
Karmanos Cancer Institute at McLaren Macomb
Mount Clemens, Michigan, 48043
1-586-493-7510
- Recruiting
Karmanos Cancer Institute at McLaren Northern
Petoskey, Michigan, 49770
231-487-3390
- Recruiting
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060
1-810-982-5200
About this study
Official title: A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy
The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:
- will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer
- the long term safety and tolerability of the TheraBionic P1 device
- assessment of how the disease responded to the TheraBionic P1 device
- Conditions
- HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
- Being tested
- TheraBionic P1
- Keywords
- therabionic
- 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 P1Device
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
| Study group | Role | What they receive |
|---|---|---|
| TheraBionic P1 device | Experimental | Self administered Amplitude-modulated electromagnetic fields three times daily Receives: Device: TheraBionic P1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as the time duration in days from treatment start to progression per physician discretion or death from any cause. Progression will be assessed every 2-3 months for 5 years
Measured: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Secondary outcomes (6)
Tolerability of the TheraBionic P1 device
Tolerability will be assessed by the proportion of participants rated as "tolerating treatment" (yes/no) throughout therapy, based on investigator assessment at each 4-week visit. Participants who discontinue treatment due to device-related symptoms or adverse events will be classified as not tolerating treatment.
Measured: From first device use through end of treatment (up to 12 months)
Overall Survival (OS)
The OS is the length of time in days from the start of treatment that participants are still alive and finishing at the date of death from any cause. Participants' survival status will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Measured: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Overall Response Rate (ORR)
The ORR is calculated as the proportion of participants with complete response (CR) or partial response (PR) per physician discretion. ORR will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Measured: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Disease control rate (DCR)
DCR is defined as the proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) per physician discretion. DCR will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Measured: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Duration of response (DOR)
DOR will be measured as the amount of time from the time of response until the first date of progressive disease (PD) per physician discretion. Participants' progression status will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Measured: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Time to progression (TTP)
Time to progression will be recorded in days starting from TheraBionic P1 treatment initiation and finishing at the date of progression per physician discretion.
Measured: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start16 Jan 2026
- Primary completion22 May 2027 (estimated)
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Assad, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227831
- Sponsor's protocol ID
- 2025-043
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy
- ClinicalTrials.gov ID
- NCT07227831
- Acronym / sponsor ID
- 2025-043
- Conditions
- HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
- Keywords
- therabionic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 May 2028 (estimated)
- First posted
- 13 Nov 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 the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:
- will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer
- the long term safety and tolerability of the TheraBionic P1 device
- assessment of how the disease responded to the TheraBionic P1 device
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 P1Self administered Amplitude-modulated electromagnetic fields three times daily |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant must have locally advanced/unresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (estrogen receptor [ER] and/or progesterone receptor [PR] >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]).
- Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one line of endocrine + CDK4/6 inhibitor therapy AND one line of cytotoxic such as chemotherapy and/or antibody drug conjugates (ADCs).
- Participant must be a woman ≥ 22 years old and must be able to understand and sign an informed consent form.
- Participant must have a life expectancy of at least 3 months.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Key exclusion criteria (7 listed)
- 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. 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.
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 P1Amplitude-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 | Device | TheraBionic P1 device |
Primary outcome
Progression Free Survival (PFS)
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
PFS is defined as the time duration in days from treatment start to progression per physician discretion or death from any cause. Progression will be assessed every 2-3 months for 5 years
6 secondary outcomes
Tolerability of the TheraBionic P1 device
Time frame: From first device use through end of treatment (up to 12 months)
Overall Survival (OS)
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
Overall Response Rate (ORR)
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Disease control rate (DCR)
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Duration of response (DOR)
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Time to progression (TTP)
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 in people with HER2-negative Breast Cancer and Hormone Receptor Positive Tumor, 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 12 inclusion and 7 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 26 Aug 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 Hadeel Assad, M.D. (1-800-527-6266, Assadh@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first). 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 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.