Testing Ultrasound Imaging to Predict Breast Cancer Response to Pre-Surgery Treatment

Who can take part

• Histologically or cytologically confirmed breast carcinoma, stage I-IV, which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy
• Disease must be measurable 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
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:; (i) hemoglobin >90 mg/dL (ii) leukocytes >3,000/mL (iii) absolute neutrophil count >1,500/mL (iv) platelets >100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal
• 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

Who cannot take part

• Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration
• Receiving any other investigational agents
• Contraindications to radiotherapy such as but not limited to:; (i) previous radiotherapy to an involved area (ii) active collagen vascular disease (iii) genetic diseases associated with hyper-radiosensitivity
• History of allergic reactions attributed to compounds of similar chemical or biologic composition
• Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy
• 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
• History of active ongoing seizure disorder
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
• Known brain metastases