Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer (ACRIN 6657)

October 7, 2013 updated by: American College of Radiology Imaging Network

Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer (I-SPY 1/ACRIN 6657)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Uab Comprehensive Cancer Center
    • California
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Research Consortium
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390-9085
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

ACRIN 6657 eligibility criteria match that of CALGB Correlative Science trial 150007. Patients with histologically-documented tumors per CALGB criteria that are at least 3 cm who choose to undergo neoadjuvant chemotherapy will be eligible to participate in the Correlative Science and Imaging companion trials (CALGB 150007/ACRIN 6657). The therapeutic regimen will consist of AC followed by a taxane for patients enrolled under the original trial protocol, and will consist of a taxane alone (Type 1) or taxane followed by AC (Type 1 followed by Type 2) for patients enrolled as part of the protocol extension.

  1. Inclusion Criteria Specific to the ACRIN 6657 MRI Study 1.1 IRB approval/Signed informed consent 1.2 Patients must have a calculated creatinine clearance of > 30 mL/min (modified Cockcroft and Gault formula) based on a serum creatinine level obtained within 28 days of registration in order to participate.

    Creatinine Clearance for Males: ([140-age (years)] X weight (kg)/(serum creatinine X 72) Creatinine Clearance for Females: Creatinine Clearance (male) X 0.85

  2. Exclusion Criteria Specific to the ACRIN 6657 MRI Study 2.1 Pregnancy 2.2 Ferromagnetic prostheses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI/MRS
MRI and MRS examinations with standard imaging, with contrast enhancement using an agent (gadopentetate dimeglumine).
Procedure: MRI/MRS
Serial MRI studies evaluated for prognostic properties related to therapeutic response.
Other Names:
  • magnetic resonance imaging
  • magnetic resonance spectoscopy
Radiation: gadopentetate dimeglumine
Imaging agent used for contrast enhancement in each of the MRIs.
Other Names:
  • contrast enhancing agent
  • MRI contrast
  • enhanced MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free three-year survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Extent of residual disease
Time Frame: 3 years
3 years
Change in the maximum dimension of the tumor over time
Time Frame: 3 years
3 years
Change in the tumor volume over time
Time Frame: 3 years
3 years
Maximum dimension of tumor size measure by MRI, mammography, and pathology
Time Frame: 3 years
3 years
MRI volume
Time Frame: 3 years
3 years
MRI peak signal enhancement ratio (SER)
Time Frame: 3 years
3 years
SER distribution (percent of tumor in highest SER category)
Time Frame: 3 years
3 years
Morphological pattern
Time Frame: 3 years
3 years
Change in tumor size by clinical exam
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Nola M. Hylton, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069496
  • ACRIN 6657 (Other Identifier: NCI CIP)
  • CALGB-150012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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