Diffuse Optical Spectroscopy Imaging in Monitoring and Predicting Response in Patients With Locally Advanced Breast Cancer Undergoing Chemotherapy Before Surgery

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 60
• Participant gender: Female

Summary

RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help measure a patient's response and allow doctors to plan better treatment.

PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and predicting response in patients with locally advanced breast cancer undergoing chemotherapy before surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American College of Radiology Imaging Network
• Collaborator: National Cancer Institute (NCI)
• Last Updated: 2013-10-14

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy (confirmed by the local site pathologist)

• Locally advanced disease

• Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy

• No contraindications for primary chemotherapy

• Tumor size ≥ 2 cm by imaging or estimated by physical exam

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• WBC ≥ 3,000/μL

• ANC ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Total bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Creatinine normal OR creatinine clearance ≥ 30 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness and/or social situations that would limit compliance with study requirements

• Not medically unstable

• At least 5 years since prior malignancy except basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy, radiotherapy, or surgery to involved breast, including hormone therapy