Three-Dimensional Ultrasound and Spectroscopy as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment

Prior treatment

• 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.

Other illness

• 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.

Other

• Known brain metastases.

• 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.