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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033397 |
Purpose
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 | Intervention |
|
Breast Cancer |
Drug: gadopentetate dimeglumine Procedure: biopsy Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: magnetic resonance imaging Procedure: mammography Procedure: ultrasound imaging |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer MRI Scans Mammography |
| Drug Information available for: | Gadolinium dtpa |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | Contrast-Enhanced Breast MRI, MRS, And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer |
| Estimated Enrollment: | 384 |
| Study Start Date: | February 2002 |
| Estimated Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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, 1-3 days 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 and at the time of surgery. Patients also undergo blood draws at the time of the first biopsy and prior to surgery. 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 384 patients will be accrued for this study within 3 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle biopsy, incisional biopsy, or fine needle aspiration (FNA)
Measurable disease
Meets one of the following staging criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No ferromagnetic prostheses including the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | ||||
| San Francisco, California, United States, 94115 | |||||
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
| United States, Minnesota | |||||
| Masonic Cancer Center at University of Minnesota | Recruiting | ||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |||||
| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
| New York, New York, United States, 10021 | |||||
| Contact: Leslie L. Montgomery 212-639-5074 | |||||
| United States, North Carolina | |||||
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting | ||||
| Chapel Hill, North Carolina, United States, 27599-7295 | |||||
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |||||
| United States, Pennsylvania | |||||
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104-4283 | |||||
| Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |||||
| United States, Texas | |||||
| Parkland Memorial Hospital | Recruiting | ||||
| Dallas, Texas, United States, 75235 | |||||
| Contact: Contact Person 214-590-5582 | |||||
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting | ||||
| Dallas, Texas, United States, 75390 | |||||
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |||||
| UT Southwestern University Hospital - Zale Lipshy | Recruiting | ||||
| Dallas, Texas, United States, 75235 | |||||
| Contact: Contact Person 214-590-3000 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Laura J. Esserman, MD, MBA | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Conway K, Edmiston SN, Tolbert D, et al.: Preliminary evaluation of p53 mutation type, tumor characteristics and clinical response among neoadjuvantly treated breast cancer patients in I-SPY1 (CALGB 150007/ACRIN 6657). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3029, S134, 2006.
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Carey LA, Oh D, Sawyer L, et al.: Gene expression subtype and p53 mutational status are correlated among neoadjuvantly treated breast cancers in UNC LCCC9819 and I-SPY1 (CALGB 150007/ACRIN 6657). [Abstract] J Clin Oncol 24 (Suppl 18): A-10048, 552s, 2006.
  |
| Study ID Numbers: | CDR0000069280, CALGB-150007 |
| First Received: | April 9, 2002 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033397 |
| Health Authority: | Unspecified |
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