Use of Quantitative Ultrasound to Guide Adaptive Chemotherapy Among Women With Breast Cancer

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 rate locally. This trial will enroll 240 randomized breast cancer patients to be assess with quantitative ultrasound to guide adaptive neoadjuvant chemotherapy as compared to standard clinical monitoring and therapy. We will evaluate the safety of its use and expect equivalence in this small patient population. This will allow for more accurate estimation of a needed sample size for a phase III superiority trial.

Inclusion criteria

• 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 criteria

• 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.