Using ultrasound to improve chemotherapy for breast cancer
A Phase II Study of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Locally Advanced Breast Cancer (LABC)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04050228 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.