Phase 1 Breast Cancer Trial, Recruiting NCT06633601 Sponsor: Sunnybrook Health Sciences Centre Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06633601
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • You are 18 years of age or older.
  • You have been diagnosed with breast cancer confirmed by a biopsy, including invasive ductal, invasive lobular, or other rare types.
  • Your breast cancer is at an intermediate to advanced stage (Stage IIA through IIIC) or has spread to other parts of the body (Stage IV).
  • A team of cancer doctors (medical, surgical, and radiation specialists) has reviewed your case and decided that radiation treatment is appropriate for you.
  • You have been referred for either standard palliative or curative radiation therapy using one of several specific dose schedules (confirm with trial site for the full list).
  • You are able to understand the study information and give your written consent to participate.
  • You weigh less than 140 kg (approximately 308 lbs).
  • The area of your cancer that needs to be treated can be reached by the special ultrasound and MRI procedure used in this trial.
  • You are able to communicate how things feel to you during the procedure.
  • Your kidney function is within a normal or acceptable range, based on blood test results.

Who may not be able to join:

  • You are pregnant or currently breastfeeding.
  • You are unable to have an MRI scan with contrast dye (a special dye used to make images clearer).
  • You have received certain chemotherapy drugs (anthracycline or taxane-based) within the past 5 days.
  • You have metal implants or breast implants.
  • You have a connective tissue disorder or a physical deformity affecting your muscles or skeleton.
  • The area of cancer to be treated has deep open wounds, bleeding, or discharge on the skin above it.
  • There is scar tissue along the path where the ultrasound treatment would be directed.
  • You have severe long-term heart, neurological, kidney, or blood-related disease.
  • Your overall health and ability to carry out daily activities is significantly limited (confirm with trial site regarding the specific scoring scale used).
  • You are unable to stay still in the required position for the duration of the treatment.
  • You have a known allergy to a substance called Definity microbubbles (a contrast agent used in the procedure).
  • You have significant heart problems, including a heart attack within the last six months, unstable chest pain, heart failure, irregular heart rhythms, a cardiac shunt, or a pacemaker.
  • You have, or have a family history of, a heart rhythm condition called QT prolongation, or you are taking certain medications known to affect heart rhythm — such as some antibiotics, antidepressants, antipsychotics, or heart rhythm medications (confirm with trial site for the full medication list).
  • A heart tracing (ECG) shows a prolonged QT interval beyond certain limits alongside heart problems (confirm with trial site for specific values).
  • You have a history of bleeding disorders or problems with blood clotting.
  • Your kidneys are severely impaired, or you are currently on dialysis.
  • Your doctor has any other concern that they feel makes participation unsuitable for you.

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 30 June 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 March 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Safety profile of MRI- guided ultrasound stimulated microbubble treatment and radiation in patients with inoperable breast/chest wall tumours or LABC.

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: 30 June 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