CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Neoadjuvant chemotherapydrug
Likely dose
Neoadjuvant chemotherapy 75 mgfrom record
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Search/NCT00462696
NCT00462696N/ACompleted

Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

Institut Bergonié·interventional·Posted Apr 19, 2007·Updated Oct 6, 2025

In Brief

A clinical study evaluating Neoadjuvant chemotherapy for Breast Cancer. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 19, 2007
Enrollment StartFeb 1, 2006
Primary CompletionDec 31, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.2 years ago

Interventions

Neoadjuvant chemotherapydrug

Neoadjuvant tehrapy as per standard practice : Patients will be treated with six cycles of neoadjuvant chemotherapy combining epirubicin (75 mg/m² on day 1) and docetaxel (75 mg/m² on day 1), administered every 21 days (Delcambre, 2005; Wenzel, 1999). This treatment regimen is in line with the latest international recommendations (Kaufmann, 2003). The addition of a leukocyte growth factor in cases of grade IV leukopenia and/or treatment postponements due to grade 3-4 toxicity will be authorized with a maximum delay of 2 weeks per cycle. Dose reductions will be authorized in 25% increments for grade 3-4 toxicity . Systematic surgical excision of the residual lesion (or the initial tumor site) will be performed between 22 and 35 days after the last chemotherapy treatment, in the form of a lumpectomy or mastectomy, depending on the residual tumor. Lymph node dissection will be systematically associated.