Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462696
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2007-04-18
Brief Title:
MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
Sponsor:
Institut Bergonié
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2008-12
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 Diagnostic procedures such as magnetic resonance imaging MRI may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment Drugs used in chemotherapy such as epirubicin and docetaxel may stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer
PURPOSE This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the feasibility reproducibility and repeatability of MRI for assessing tumor vascularity in women receiving neoadjuvant chemotherapy for infiltrative breast cancer
Secondary
Compare the results obtained by semiquantitative measurement of vascularization MRI vs traditional empirical evaluation
Evaluate the MRI accuracy for the measurement of tumoral volume after completion of chemotherapy
OUTLINE This is an uncontrolled nonrandomized study
Patients receive neoadjuvant chemotherapy comprising epirubicin hydrochloride IV and docetaxel IV on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo dynamic-contrast MRI before treatment 3 weeks after the first course of chemotherapy and 3 weeks after the completion of chemotherapy They also undergo a bilateral mammogram and sonography and clinical examination
Within 22-35 days after completion of chemotherapy patients undergo breast-conserving surgical resection of tumor and lymph nodes or mastectomy
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Evaluate the feasibility reproducibility and repeatability of MRI for assessing tumor vascularity in women receiving neoadjuvant chemotherapy for infiltrative breast cancer
Secondary
Compare the results obtained by semiquantitative measurement of vascularization MRI vs traditional empirical evaluation
Evaluate the MRI accuracy for the measurement of tumoral volume after completion of chemotherapy
OUTLINE This is an uncontrolled nonrandomized study
Patients receive neoadjuvant chemotherapy comprising epirubicin hydrochloride IV and docetaxel IV on day 1 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo dynamic-contrast MRI before treatment 3 weeks after the first course of chemotherapy and 3 weeks after the completion of chemotherapy They also undergo a bilateral mammogram and sonography and clinical examination
Within 22-35 days after completion of chemotherapy patients undergo breast-conserving surgical resection of tumor and lymph nodes or mastectomy
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IB-2005-37 | None | None | None |
| INCA-RECF0144 | None | None | None |
| IB-ISNA | None | None | None |