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

American College of Radiology Imaging Network

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Radiation: gadopentetate dimeglumine

Procedure: MRI/MRS

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00043017

ACRIN 6657 (Other Identifier)

CALGB-150012

CDR0000069496

Details and patient eligibility

About

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.

Full 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.

Enrollment

356 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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