Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Comparing results of diagnostic procedures performed before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment.

PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle biopsy, incisional biopsy, or fine needle aspiration (FNA)

• Incisional biopsy must result in < 10% removal of gross residual disease

• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan OR

• Nonmeasurable disease

• Meets one of the following staging criteria:

• Stage II or III disease

• T4, any N, M0, including clinical or pathologic inflammatory disease

• Regional stage IV disease where supraclavicular/infraclavicular lymph nodes are only site of metastasis

• No clinical or imaging evidence of distant metastasis

• Metaplastic carcinomas allowed

• Synchronous bilateral primaries allowed if the more advanced tumor meets staging criteria

• Patients for whom FNA was used to confirm initial diagnosis must have histologically confirmed invasive carcinoma by the start of chemotherapy

• Her-2/neu status known

• Currently receiving neoadjuvant chemotherapy consisting of a taxane-based regimen alone or followed by an anthracycline-based regimen

• Concurrent enrollment in the ACRIN-6657/CALGB-150012 imaging protocol required

• Hormone receptor status:

• Any estrogen receptor or progesterone receptor status

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female Cardiovascular

• No uncontrolled or severe cardiovascular disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• No ferromagnetic prostheses including the following:

• Metallic implants not compatible with a magnetic resonance imaging machine

• Heart valves

• Aneurysm clips

• Orthopedic prosthesis

• Any metallic fragments anywhere in the body

PRIOR CONCURRENT THERAPY:

Chemotherapy

• See Disease Characteristics

• No prior chemotherapy to the ipsilateral breast for this malignancy

Endocrine therapy

• At least 4 weeks since prior tamoxifen or raloxifene

Radiotherapy

• No prior radiotherapy to the ipsilateral breast for this malignancy

Other

• No other prior cytotoxic regimens