Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043017
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2002-08-05
Brief Title:
Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
Contrast-Enhanced Breast MRI For Evaluation Of Patients Undergoing Neoadjuvant Treatment For Locally-Advanced Breast Cancer I-SPY 1ACRIN 6657
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRIN 6657
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
PURPOSE Diagnostic trial to study the effectiveness of MRI in monitoring tumor response in women who are receiving chemotherapy for stage III breast cancer
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACRIN 6657 | OTHER | None | None |
| CALGB-150012 | Other Identifier | NCI CIP | None |