Study of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer After Progression

N/ANot Yet RecruitingNCT07672431

Barbara Ann Karmanos Cancer Institute24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Triple Negative Breast Cancer

Interventions

TheraBionic P1

Eligibility

Sex: FEMALEMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 have a washout period of at least 14 days between the last line of treatment and the start of study treatment. * Participant must be a woman of 22 years of age or older. * Participant must have a life expectancy of at least three months * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2 * It is unknown 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 and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 12 weeks after treatment discontinuation * 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 from sexual intercourse 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 child-bearing potential, agree to use at least one highly effective AND at least one additional method of contraception. Withdrawal is not an acceptable contraceptive method. Exclusion Criteria: * 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 * 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 who plan to receive calcium channel blockers and any agent blocking L-type of T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, supplemental vitamin C/ascorbic acid, etc.) unless their medical treatment is discontinued prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study * Participants who plan to receive anticancer therapy that blocks L-type or T-type voltage gated calcium channels (i.e., eribulin, rucaparib, or niraparib) as part of their third line treatment. Participants who have received eribulin, rucaparib, or niraparib as part of a previous line of therapy are eligible, provided there has been at least 14 days between the last date of treatment and the start of study treatment. * Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan * Participants with a known severe (e.g., anaphylactic) allergy to nickel

Outcomes

Primary Outcomes

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.

Time frame: 6 months after start of treatment

Secondary Outcomes

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.

Time frame: From baseline to up to 1 year after treatment initiation

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.

Time frame: From baseline to up to 5 years after treatment initiation

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.