Ultrasound Imaging and Spectroscopy as Early Indicators of Locally-Advanced Breast Cancer Response

The primary objective in this study is to identify optimal ultrasound spectroscopy parameters that can be used as an early predictor of pathological complete or partial response in women with locally advanced breast cancer receiving treatment with chemotherapy or combined modality chemotherapy and radiotherapy. A secondary objective is to perform an inter-user variability comparison by comparing second site data analysis outcomes with central co-coordinating site data analysis. The overarching goal of this research is to transform the delivery of neoadjuvant chemotherapy using quantitative ultrasound, which is non-invasive, inexpensive and portable to assess breast cancer therapies through functional imaging, in which tumour cell death is detected. By detecting cell death early in a treatment on the order of hours to days, rather than traditional anatomical assessments that take place weeks to months after the completion of therapy, ineffective therapies could be switched to more efficacious treatments or aggressive salvage therapy which has shown to already benefit patients. This has the potential of improving survival in addition to sparing patients unnecessary side effects of treatments that may span weeks to months. The investigators will use these quantitative methods to evaluate treatments with neoadjuvant chemotherapy in women with locally advanced breast cancer. This investigation will track the spatio-temporal changes in quantitative ultrasound surrogates of treatment response during neoadjuvant chemotherapy of locally advanced breast cancer and use these parameters to adapt clinical treatment. The study specifically will expand on single- institution research underway and involve a second clinical site. Data will be independently collected and analysis carried out at that site and at the co-ordinating site for comparison evaluating technology-use feasibility and reproducibility of results.

Inclusion criteria

• Histologically or cytologically confirmed locally advanced breast carcinoma which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
• Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment
• Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy of at least 6 months
• Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures

Exclusion criteria

• History of allergic reactions attributed to compounds of similar chemical or biologic composition
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.