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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer



Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer

For Condition: stage 3B breast cancer,stage 3A breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may help determine the effectiveness of chemotherapy in killing breast cancer and allow doctors to plan more effective treatment. PURPOSE: Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in women who are receiving chemotherapy for stage III breast cancer.
Details: OBJECTIVES: - Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced magnetic resonance imaging (MRI) that are predictive of pathologic remissions and survival in women with stage III breast cancer. - Identify two groups of patients who have statistically different 3-year disease-free survival using MRI measurements of tumor response to neoadjuvant chemotherapy. - Determine whether MRI measurements of tumor response after the first course of neoadjuvant chemotherapy can predict which of these patients will ultimately have poor clinical response to chemotherapy. - Compare the accuracy of MRI vs mammography in predicting the extent of residual disease as determined by histopathology in these patients. - Determine whether initial MRI tumor characteristics (morphologic and vascular patterns) predict pathological response and/or survival in these patients. - Estimate the conditional probability of response to paclitaxel based on MRI measurements of response to doxorubicin and cyclophosphamide in these patients. OUTLINE: This is a multicenter study. Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast within 2 weeks before beginning neoadjuvant chemotherapy, at least 2 weeks after the first course and before the second course of doxorubicin and cyclophosphamide (AC), between AC and paclitaxel chemotherapy regimens (if the patient continues to paclitaxel), and 3-4 weeks after final neoadjuvant chemotherapy treatment (1-2 weeks before surgery). Patients also undergo mammograms and possibly ultrasounds that coincide with the first and last MRI. Core or needle biopsy is performed after the first MRI but before the first course of AC, 24-96 hours after the first course of AC, and between AC and paclitaxel chemotherapy regimens (if the patient continues to paclitaxel). Patients are followed every 6 months for 7-10 years. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of stage III breast cancer - Concurrent enrollment in the CALGB-49808 trial OR - Receiving neoadjuvant chemotherapy - Anthracycline-based regimen (alone or followed by a taxane) AND - Enrolled in CALGB Correlative Science trial 150007 - Patients who decline participation in CALGB-49808 or those with HER-2/neu-negative tumors are eligible if tumor is at least 3 cm and they choose to undergo neoadjuvant chemotherapy - Hormone receptor status: - Not specified 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 pacemaker Other - Not pregnant - Fertile patients must use effective contraception - No contraindications to MRI (e.g., ferromagnetic prostheses, cranial vascular clips, or claustrophobia) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
NolaHylton,  Study Chair,  University of California, San Francisco

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390-9085
United States
Recruiting Paul  Weatherall 214-648-5800

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599
United States
Recruiting Etta  Pisano 919-966-6957

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Erini  Makariou 202-444-3394

University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195-6043
United States
Recruiting Connie  Lehman 206-598-4100

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Gregory  Karczmar 773-702-0214

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Mark  Rosen 215-662-3107

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Elizabeth  Morris 202-754-3462

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Nola  Hylton 415-353-9510

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35233
United States
Recruiting Wanda  Bernreuter 205-801-8317


Additional Information:
Study ID Numbers:
  CDR0000069496;  CALGB-150013,ACRIN-6657
Study Start Date: 
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043017

Other Stage 3b Breast Cancer Studies:
1. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer

2. Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

3. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer

4. Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer

5. Combination Chemotherapy in Treating Women With Breast Cancer

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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer

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