An interventional study of TheraBionic P1 in HER2-negative Breast Cancer, Hormone Receptor Positive Tumor and Advanced Breast Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Recruiting at 8 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Barbara Ann Karmanos Cancer Institute · Not applicable, Interventional, and Treatment
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:
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 82 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 161 studies on the registry; 19 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Self administered Amplitude-modulated electromagnetic fields three times daily
Device: TheraBionic P1
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
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
Time frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From start of treatment to 5 years after treatment initiation or death, whichever comes first
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for May 2027, 16 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 16 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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