Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033397
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2002-04-09
Brief Title:
Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Contrast-Enhanced Breast MRI MRS And Correlative Science Studies To Characterize Tumor Response In Patients Undergoing Neoadjuvant Treatment For Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
RATIONALE Comparing results of diagnostic procedures performed before during and after chemotherapy may help doctors predict a patients response to treatment and help plan the most effective treatment
PURPOSE Diagnostic trial to study magnetic resonance imaging MRI and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer
PURPOSE Diagnostic trial to study magnetic resonance imaging MRI and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer
Detailed Description:
OBJECTIVES
Primary
Support accrual to the ACRIN-6657CALGB-150012 magnetic resonance imaging MRI correlative science study
Determine whether molecular markers alone or in combination with MRI at the time of diagnosis or early in the course of therapy predict 3-year disease-free survival DFS in women with locally advanced breast cancer who are receiving neoadjuvant chemotherapy
Identify two groups of participants who have statistically different 3-year DFS based on 1 or more biomarkers including MRI
Determine whether biomarkers in combination with MRI early in the course of chemotherapy improve the prediction of 3-year DFS and are at least as good of a predictor of DFS as residual disease at the time of surgery in these patients
Determine whether molecular markers are associated with specific imaging patterns seen on MRI of these patients
Predict response with MRI results and marker data from cell cycle check points proliferation angiogenesis hormone receptors and molecular profiles in these patients
Secondary
Determine the molecular predictors of lack of radiologic complete response CR in HER-2neu negative patients immunohistochemistry IHC score of 0 1 2 and fluorescence in situ hybridization FISH not amplified after a neoadjuvant anthracycline-based regimen
Determine the molecular predictors of lack of radiologic CR in HER-2neu positive patients IHC 3 or FISH amplified 20 after a neoadjuvant anthracycline-based regime followed by a taxane alone regimen or in combination with trastuzumab
Determine the molecular predictors of complete magnetic resonance imaging radiologic response to a neoadjuvant anthracycline-based regimen when gene expression profiling is performed in a sequential real-time fashion
OUTLINE This is a diagnostic multicenter study conducted concurrently with CALGB-150012ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy
Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging MRI of the breast before initiation 1-3 days after initiation and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan
Patients undergo biopsies before initiation and at the time of surgery Patients also undergo blood draws at the time of the first biopsy and prior to surgery Serum and tissue samples are used to assess biomarkers of genetic instability cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness markers of apoptotic potential as predictors for taxane responsiveness in vivo angiogenesis hormone receptors and molecular profiles using immunohistochemical methods
Mammograms and possibly ultrasounds are performed prior to and after chemotherapy before surgery
Patients are followed every 6 months for 5 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 384 patients will be accrued for this study within 3 years
Primary
Support accrual to the ACRIN-6657CALGB-150012 magnetic resonance imaging MRI correlative science study
Determine whether molecular markers alone or in combination with MRI at the time of diagnosis or early in the course of therapy predict 3-year disease-free survival DFS in women with locally advanced breast cancer who are receiving neoadjuvant chemotherapy
Identify two groups of participants who have statistically different 3-year DFS based on 1 or more biomarkers including MRI
Determine whether biomarkers in combination with MRI early in the course of chemotherapy improve the prediction of 3-year DFS and are at least as good of a predictor of DFS as residual disease at the time of surgery in these patients
Determine whether molecular markers are associated with specific imaging patterns seen on MRI of these patients
Predict response with MRI results and marker data from cell cycle check points proliferation angiogenesis hormone receptors and molecular profiles in these patients
Secondary
Determine the molecular predictors of lack of radiologic complete response CR in HER-2neu negative patients immunohistochemistry IHC score of 0 1 2 and fluorescence in situ hybridization FISH not amplified after a neoadjuvant anthracycline-based regimen
Determine the molecular predictors of lack of radiologic CR in HER-2neu positive patients IHC 3 or FISH amplified 20 after a neoadjuvant anthracycline-based regime followed by a taxane alone regimen or in combination with trastuzumab
Determine the molecular predictors of complete magnetic resonance imaging radiologic response to a neoadjuvant anthracycline-based regimen when gene expression profiling is performed in a sequential real-time fashion
OUTLINE This is a diagnostic multicenter study conducted concurrently with CALGB-150012ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy
Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging MRI of the breast before initiation 1-3 days after initiation and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan
Patients undergo biopsies before initiation and at the time of surgery Patients also undergo blood draws at the time of the first biopsy and prior to surgery Serum and tissue samples are used to assess biomarkers of genetic instability cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness markers of apoptotic potential as predictors for taxane responsiveness in vivo angiogenesis hormone receptors and molecular profiles using immunohistochemical methods
Mammograms and possibly ultrasounds are performed prior to and after chemotherapy before surgery
Patients are followed every 6 months for 5 years and then annually for up to 10 years
PROJECTED ACCRUAL A total of 384 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000069280 | REGISTRY | NCI Physician Data Query | None |
| CALGB-150007 | None | None | None |