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Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
This study is currently recruiting participants.
Study NCT00043017   Information provided by National Cancer Institute (NCI)
First Received: August 5, 2002   Last Updated: July 15, 2009   History of Changes

August 5, 2002
July 15, 2009
May 2002
May 2005   (final data collection date for primary outcome measure)
Disease-free three-year survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00043017 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 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 ]
 
Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer

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.

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.

 
Interventional
Diagnostic
Breast Cancer
  • Procedure: magnetic resonance imaging
  • Procedure: radiomammography
  • Procedure: spectroscopy
  • Radiation: gadopentetate dimeglumine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
May 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of stage III breast cancer

    • T2 or T3 tumors that is at least 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
Female
18 Years and older
No
 
United States
 
NCT00043017
 
CDR0000069496, ACRIN-6657, CALGB-150012
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Nola M. Hylton, PhD UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP