The goal of this clinical trial is to learn if adding the TheraBionic P1 device to standard of care third line treatment for adult women with metastatic triple negative breast cancer (mTNBC) who have failed, not tolerated, or progressed on standard first- and second-line treatment options can work better than the standard of care alone. The main questions it aims to answer is:
* will the addition of the TheraBionic P1 device to standard of care third line treatment affect progression free and overall survival in these participants
Participant must have histologically confirmed invasive breast cancer that is hormone receptor (HR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative according to the American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Estrogen Receptor (ER) and progesterone receptor (PR) < 1% and HER2 negative by immuno-histochemistry (IHC) and/or fluorescent in situ hybridization [FISH]
Participant must have evaluable disease as defined by the investigator using CT, MRI, or positron emission tomography (PET) scan
Participant must have refractory disease and failed, not tolerated, or progressed on at least two lines of prior standard therapeutic regimens for mTNBC.
Participant must be a woman of 22 years of age or older.
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 with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain magnetic resonance imaging (MRI) with and without contrast within 8 weeks of signing consent.
Participants who are taking any other investigational drugs
Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
Single group
TheraBionic P1
DeviceTheraBionic P1 is amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device added to any third line treatment for triple negative breast cancer
6 month Progression Free Survival (PFS6)
PFS is defined as the interval from treatment initiation to the date of disease progression of death from any cause, whichever occurs first. The treating investigator will determine disease progression. PFS6 will be calculated as the proportion of participants who are alive without progression at six months post-treatment initiation.
Changes in Quality of Life Scores (QOL)
QOL scores are evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30). It is 30-item questionnaire assessing cancer patients' health-related quality of life, covering functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, pain, nausea, dyspnoea, etc.), and a global health/QoL scale. We will record the time to deterioration of QOL, physical functioning, and role functioning, as reported by the participant, with deterioration defined as a decrease from baseline of 10 points or more on the EORTC QLQ - C30 maintained for two consecutive assessments or a decrease of 10 points or more in one assessment followed by death from any cause within three weeks.
Overall Survival (OS)
Participants will be followed for survival status every six months for five years after treatment is initiated. OS is defined as the interval from treatment initiation to the date of death from any cause. The distribution of time-to-event data (OS) will be graphically summarized using a Kaplan-Meier (KM) curve, with corresponding median and two-sided 95% Confidence Level (CI) computed using KM estimates. OS rates every six months post-treatment will be estimated using KM estimates with two-sided 95% CIs provided for each time point.
Progression Free Survival
Participants will be followed for progression status every six months for five years after treatment is initiated. Participants will not be followed for progression if they start another anti-cancer therapy during this time. PFS is defined as the interval from treatment initiation to the date of disease progression of death from any cause, whichever occurs first. The treating investigator will determine disease progression. The distribution of time-to-event data (PFS) will be graphically summarized using a Kaplan-Meier (KM) curve, with corresponding median and two-sided 95% CI computed using KM estimates. PFS rates every six months post-treatment will be estimated using KM estimates with two-sided 95% CIs provided for each time point.
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Barbara Ann Karmanos Cancer Institute
Lead sponsor
THERABIONIC INC.
Collaborator
Ucancervive
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
