Using ultrasound to improve chemotherapy for breast cancer
Official title: A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
Run by Sunnybrook Health Sciences Centre · NCT04050228 · Data updated 2026-11-12
This study is testing whether using ultrasound to monitor chemotherapy can help women with breast cancer get better treatment adjustments and outcomes compared to standard methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | June 13, 2018 |
| Main results expected | June 2025 |
| Study ends | June 2029 |
| Registry record updated | December 28, 2023 |
| Trial ID | NCT04050228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 and older with a diagnosis of breast cancer and a primary tumor larger than 2 cm who are eligible for neoadjuvant chemotherapy.
✕Probably not a fit
Patients with inflammatory breast cancer or those with contraindications to neoadjuvant treatment, such as pregnancy or severe comorbidities, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the feasibility of using quantitative ultrasound to guide adaptive neoadjuvant chemotherapy in women with breast cancer. It will compare the effectiveness of this ultrasound-guided approach against standard clinical monitoring and therapy. By detecting cell death early in the treatment process, the study seeks to enable timely adjustments to chemotherapy regimens, potentially leading to better patient outcomes. A total of 240 patients will be randomized to assess the safety and efficacy of this innovative method.
Why it matters
Potential benefit: If successful, this approach could lead to more effective chemotherapy treatments for breast cancer patients by allowing for quicker adjustments based on treatment response.
How similar studies have gone: While the use of ultrasound in monitoring treatment response is established, this specific approach of guiding chemotherapy based on quantitative ultrasound is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women ≥ 18 years of age 2. Diagnosis of breast cancer with a primary tumour \>2cm in size 3. With conditions meeting criteria for chemotherapy administration 4. Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L) 5. Creatinine ≤175 µmol/L 6. Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal 7. Cardiac function (left ventricular ejection fraction) ≥55% 8. Eligible for neoadjuvant chemotherapy. Exclusion Criteria: 1. Inflammatory breast cancer 2. Contraindications to neoadjuvant treatment including pregnancy or lactation 3. Past medical history of connective tissue disease 4. Past history of dermatologic disease involving the breast 5. Eastern Cooperative Group Status (ECOG) ≥3 6. No peripheral neuropathy of a severity of grade ≥2 7. Evidence of distant metastatic disease 8. Known sensitivity to components present in ultrasound gel.
Where it's running
-
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Gregory J Czarnota, PhD, MD — Sunnybrook Health Sciences Centre
- Study coordinator: Gregory J Czarnota, PhD, MD
- Email: gregory.czarnota@sunnybrook.ca
- Phone: (416) 480-6128
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.