Breast Cancer Trial, Not Yet Recruiting NCT07227831 Sponsor: Barbara Ann Karmanos Cancer Institute Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT07227831
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with breast cancer that has spread or cannot be surgically removed, and whose cancer tests show it is hormone receptor (HR) positive and HER2 negative (based on specific laboratory testing guidelines).
  • People whose cancer has continued to grow, or who could not tolerate, at least one hormone-based treatment combined with a CDK4/6 inhibitor drug, AND at least one chemotherapy treatment or a type of targeted drug called an antibody drug conjugate (ADC).
  • Women aged 22 or older who are able to read, understand, and sign a consent form agreeing to take part.
  • People with a life expectancy of at least 3 months.
  • People with a physical functioning score of 0, 1, or 2 on a standard medical scale called the ECOG scale, meaning they are fully active to being able to care for themselves but spending less than half of waking hours in bed (confirm with trial site).
  • People who agree to avoid becoming pregnant from the start of treatment until at least 30 days after the last treatment session, because the effects of this treatment on pregnancy or fetal development are not yet known.
  • People who meet at least one of the following conditions related to pregnancy risk: have had surgery to remove the uterus, both ovaries, or both fallopian tubes; have had no menstrual periods for at least 12 months before the screening visit for reasons unrelated to other medical causes; agree to practice complete abstinence from sex in a way that is consistent with their normal lifestyle (note: calendar-based or other tracking methods of abstinence are not accepted); are not in a relationship where pregnancy could occur; or, if pregnancy is possible, agree to use at least one accepted method of contraception (withdrawal is not accepted as a contraceptive method).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have another active cancer diagnosis, unless the trial doctor determines it is unlikely to affect the safety of the study or its results.
  • People who are currently taking part in another clinical trial involving an experimental drug.
  • People who are pregnant or currently breastfeeding (breastfeeding would need to be stopped before joining).
  • People who have active inflammation, ulcers, or other conditions affecting the inside of the mouth or gums that could interfere with using the trial device — for example, mouth sores, oral thrush, bleeding lesions, oral herpes, or similar conditions.
  • People who are taking certain blood pressure or calcium-regulating medications called calcium channel blockers (for example, amlodipine, nifedipine) or other drugs that block specific calcium channels (for example, ethosuximide, high-dose vitamin C), unless those medications are stopped at least one day before treatment begins and the person agrees not to take them for the entire duration of the trial.
  • People who are unwilling or unable to follow the study requirements, or who have a cognitive or physical condition that would prevent them from using the treatment device.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 1-800-527-6266

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Barbara Ann Karmanos Cancer Institute
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
22 May 2027

Primary endpoints

Progression Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov