MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00462696
• Lead Sponsor: Institut Bergonié

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.

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-19
• Status Verified: 2008-12
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility and repeatability of MRI

Secondary Outcome Measures

Name	Time	Method
Results of MRI vs mammogram
MRI accuracy

Trial Locations

Locations (1)

Institut Bergonie; 🇫🇷 Bordeaux, France