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

Sponsor

American College of Radiology Imaging Network (Other)

Overall Status

Completed

CT.gov ID

NCT00043017

Collaborator

National Cancer Institute (NCI) (NIH)

356

Enrollment

Locations

Arm

106

Duration (Months)

32.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: MRI/MRS Radiation: gadopentetate dimeglumine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

356 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Disease-free three-year survival [3 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
3	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
4	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
5	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
6	Mayo Clinic Cancer Research Consortium	Rochester	Minnesota	United States	55905
7	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
8	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
9	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
10	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
11	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390-9085