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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on August 5, 2002.   Last Updated on April 10, 2010   History of Changes
Sponsor: American College of Radiology Imaging Network
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00043017
  Purpose

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.


Condition Intervention
Breast Cancer
 Procedure: magnetic resonance imaging
Procedure: radiomammography
Procedure: spectroscopy
Radiation: gadopentetate dimeglumine

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer MRI Scans
Drug Information available for: Gadolinium DTPA
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free three-year survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extent of residual disease [ Designated as safety issue: No ]
  • Change in the maximum dimension of the tumor over time [ Designated as safety issue: No ]
  • Change in the tumor volume over time [ Designated as safety issue: No ]
  • Maximum dimension of tumor size measure by MRI, mammography, and pathology [ Designated as safety issue: No ]
  • MRI volume [ Designated as safety issue: No ]
  • MRI peak signal enhancement ratio (SER) [ Designated as safety issue: No ]
  • SER distribution (percent of tumor in highest SER category) [ Designated as safety issue: No ]
  • Morphological pattern [ Designated as safety issue: No ]
  • Change in tumor size by clinical exam [ Designated as safety issue: No ]

Study Start Date: May 2002
Estimated Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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) and magnetic resonance spectroscopy of the breast within 4 weeks before beginning neoadjuvant chemotherapy, 20-28 hours or 48-96 hours after the first course of doxorubicin and cyclophosphamide (Type 1 chemotherapy), between Type 1 chemotherapy and paclitaxel chemotherapy regimens (Type 2 chemotherapy) (MRI only) if the patient continues to Type 2 chemotherapy, 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 Type 1 chemotherapy and between Type 1 chemotherapy and Type 2 chemotherapy (if the patient continues to Type 2 chemotherapy).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III breast cancer per CALGB criteria

    • Tumor that is ≥ 3 cm
  • Concurrent enrollment in the CALGB-49808 trial OR
  • Receiving neoadjuvant chemotherapy consisting of a taxane-based regimen alone (chemotherapy Type 1) or followed by an anthracycline-based regimen (chemotherapy Type 2) 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 prosthesis, cranial vascular clips, or claustrophobia)
  • Creatinine clearance > 30 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043017

Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center     205-934-0309        
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, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center     202-444-0381        
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
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        
Mayo Clinic Cancer Research Consortium Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - Mayo Clinic Cancer Research Consortiu     507-538-7623        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Elizabeth Morris     212-639-2236        
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
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390-9085
Contact: Paul Weatherall, MD     214-684-3711        
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Investigators
Study Chair: Nola M. Hylton, PhD University of California, San Francisco
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Esserman LJ, Perou C, Cheang M, et al.: Breast cancer molecular profiles and tumor response of neoadjuvant doxorubicin and paclitaxel: The I-SPY TRIAL (CALGB 150007/150012, ACRIN 6657). [Abstract] J Clin Oncol 27 (Suppl 15): A-LBA515, 2009.
Hylton N, Blume J, Gatsonis C, et al.: MRI tumor volume for predicting response to neoadjuvant chemotherapy in locally advanced breast cancer: findings from ACRIN 6657/CALGB 150007. [Abstract] J Clin Oncol 27 (Suppl 15): A-529, 2009.
Lin C, Moore D, DeMichele A, et al.: Detection of locally advanced breast cancer in the I-SPY TRIAL (CALGB 150007/150012, ACRIN 6657) in the interval between routine screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-1503, 2009.
Pradhan SM, Carey L, Edmiston S, et al.: P53 mutation and differential response to neoadjuvant chemotherapy in women with locally advanced breast cancer: results from the I-SPY trial (CALGB 150007/1500012 and ACRIN 6657). [Abstract] J Clin Oncol 27 (Suppl 15): A-11099, 2009.
Gomez RE, Zakhireh J, Moore D, et al.: Sentinel node biopsy performed in the neoadjuvant setting for breast cancer: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-202, 2008.
Hylton NM, Blume JD, Bernreuter WK, et al.: Comparison of MRI endpoints for assessing breast cancer response to neoadjuvant treatment: preliminary findings of the American College of Radiology Imaging Network (ACRIN) trial 6657. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6043, 2008.
Livasy C, Carey L, DeMichele A, et al.: Influence of anthracycline- and taxane-based neoadjuvant chemotherapy on tumor HER2 protein expression in locally advanced breast cancers: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-703, 2008.
Livasy C, Carey L, DeMichele A, et al.: Biomarkers associated with pathologic complete response to neoadjuvant chemotherapy in women with locally advanced breast cancer: results from the I-SPY TRIAL (CALGB 150007/150012 & ACRIN 6657). [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-5102, 2008.
Van 't Veer LJ, Das D, DeMichele A, et al.: Neoadjuvant response in the context of a biologically defined low or high risk tumor has a different clinical consequence, the I-SPY trial (CALGB 150007/150012, ACRIN 6657). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2003, 2009.
Wolf DM, Das D, Lenburg ME, et al.: From the lab to the clinic: gene-expression profiles that are associated with Mek-inhibitor sensitivity in vitro are coordinately co-expressed in breast cancer biopsy samples from the I-SPY Trial (CALGB 150007/150012, ACRIN 6657). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-2042, 2009.
Esserman LJ, van't Veer LJ, Perou C, et al.: Biology of breast cancers that present as interval cancers and at young age should inform how we approach early detection and prevention. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6034, 2008.
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.

ClinicalTrials.gov Identifier: NCT00043017     History of Changes
Other Study ID Numbers: CDR0000069496, ACRIN-6657, CALGB-150012
Study First Received: August 5, 2002
Last Updated: April 10, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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