MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
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.
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Diagnostic
|Official Title:||Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer|
- Reproducibility and repeatability of MRI [ Designated as safety issue: No ]
- Results of MRI vs mammogram [ Designated as safety issue: No ]
- MRI accuracy [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Evaluate the feasibility (reproducibility and repeatability) of MRI for assessing tumor vascularity in women receiving neoadjuvant chemotherapy for infiltrative breast cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462696
|Bordeaux, France, 33076|
|Study Chair:||Fabienne Valentin, MD||Institut Bergonié|