HER2-negative Breast Cancer study: TheraBionic P1
Official title A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer
ClinicalTrials.gov ID: NCT07227831
What this study is testing
- What it's testing
- This study is testing whether a new device helps people live longer. It also checks how safe the device is over time.
- Who it's for
- You may be able to join if you have advanced breast cancer that has spread.
- What's involved
- You would use the TheraBionic P1 device. The team will check how your body reacts to it.
- Time commitment
- The study lasts for a long time to see if it helps you live longer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Participant must have locally advanced/unresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2)...
- Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one...
- 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.
You likely can't join if
- Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and how...
- 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...
- Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for...
- Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine...
- Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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.
- 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.
- Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and how well it works 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Bay City, Michigan, United States
- Clarkston, Michigan, United States
- Detroit, Michigan, United States
- Flint, Michigan, United States
- Lapeer, Michigan, United States
- Mount Clemens, Michigan, United States
- Petoskey, Michigan, United States
- Port Huron, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bay City, Michigan, United States; Clarkston, Michigan, United States; Detroit, Michigan, United States; Flint, Michigan, United States; Lapeer, Michigan, United States; Mount Clemens, Michigan, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.