Status:
RECRUITING
Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to assess the feasibility of randomizing breast cancer patients to quantitative ultrasound to guide adaptive Neoadjuvant Chemotherapy as compared to standard cli...
Detailed Description
This study phase II will demonstrate the use of quantitative ultrasound to guide adaptive chemotherapy for patients with breast cancer. The primary endpoint will be measurement of improved response ra...
Eligibility Criteria
Inclusion
- Women ≥ 18 years of age
- Diagnosis of breast cancer with a primary tumour \>2cm in size
- With conditions meeting criteria for chemotherapy administration
- Normal hematological blood counts (hemoglobin ≥ 100 g/l, platelet count ≥ 100 x 109, absolute neutrophil count ≥ 2.0 x109 cells per L)
- Creatinine ≤175 µmol/L
- Liver enzymes (AST and ALT) ≤ 1.5 times upper limit of normal
- Cardiac function (left ventricular ejection fraction) ≥55%
- Eligible for neoadjuvant chemotherapy.
Exclusion
- Inflammatory breast cancer
- Contraindications to neoadjuvant treatment including pregnancy or lactation
- Past medical history of connective tissue disease
- Past history of dermatologic disease involving the breast
- Eastern Cooperative Group Status (ECOG) ≥3
- No peripheral neuropathy of a severity of grade ≥2
- Evidence of distant metastatic disease
- Known sensitivity to components present in ultrasound gel.
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04050228
Start Date
June 13 2018
End Date
June 1 2029
Last Update
December 28 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5