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.

Condition	Treatment or Intervention
stage II breast cancer stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer inflammatory breast cancer	Drug: gadopentetate dimeglumine  Procedure: biological markers  Procedure: biopsies  Procedure: diagnostic test  Procedure: immunohistochemistry  Procedure: magnetic resonance imaging  Procedure: mammography  Procedure: ultrasonography

Further Study Details: 

OBJECTIVES:

• Support accrual to the ACRIN-6657/CALGB-150012 magnetic resonance imaging (MRI) correlative science study.
• Determine whether molecular markers, alone or in combination with MRI, at the time of diagnosis or early in the course of therapy, predict 3-year disease-free survival (DFS) in women with locally advanced breast cancer who are receiving neoadjuvant chemotherapy.
• Identify two groups of participants who have statistically different 3-year DFS, based on 1 or more biomarkers, including MRI.
• Determine whether biomarkers, in combination with MRI, early in the course of chemotherapy, improve the prediction of 3-year DFS and are at least as good of a predictor of DFS as residual disease at the time of surgery in these patients.
• Determine whether molecular markers are associated with specific imaging patterns seen on MRI of these patients.
• Predict response with MRI results and marker data from cell cycle check points, proliferation, angiogenesis, hormone receptors, and molecular profiles in these patients.

OUTLINE: This is a diagnostic, multicenter study conducted concurrently with CALGB-150012/ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy.

Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 2 weeks after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan.

Patients undergo biopsies before initiation, 1-4 days after initiation, after completion of neoadjuvant anthracycline-based chemotherapy, at the time of surgery, and at the beginning of taxane chemotherapy (if applicable). Patients also undergo blood draws at the time of the first biopsy and 2-4 days after initiation of anthracycline therapy. Serum and tissue samples are used to assess biomarkers of genetic instability, cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness, markers of apoptotic potential as predictors for taxane responsiveness in vivo, angiogenesis, hormone receptors, and molecular profiles using immunohistochemical methods.

Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery).

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 a neoadjuvant anthracycline-based regimen alone or followed by a taxane
• 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

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

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: Biologic therapy

• Not specified

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

Surgery

• Not specified

Other

• No other prior cytotoxic regimens

California
      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States; Recruiting
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States; Recruiting
District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Illinois
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7305,  United States; Recruiting
Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Texas
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-8852,  United States; Recruiting

Study chairs or principal investigators

Laura J. Esserman, MD, MBA,  Study Chair,  University of California, San Francisco   

Study ID Numbers:  CDR0000069280; CALGB-150007; NCT00033397
Record last reviewed:  March 2004
Last Updated:  April 4, 2005
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033397
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08