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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: epirubicin hydrochloride
* Procedure: conventional surgery
* Procedure: dynamic contrast-enhanced magnetic resonance imaging
* Procedure: neoadjuvant therapy
* Procedure: radiomammography


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed infiltrative breast cancer meeting 1 of the following criteria: Operable T2 or T3, M0 disease Locally advanced disease (T4a, b, or c) No T4d disease Indication for neoadjuvant chemotherapy before breast-conserving surgery No desire by patient for complete mastectomy No overexpression of HER-2 No multifocal tumor Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Life expectancy > 6 months No contraindication to MRI with contrast, including any of the following: Claustrophobia Prior major allergies Cardiac pacemaker Surgical clips Certain cardiac valves Sunken or hollow filters Implanted pump Cochlear implants Metallic foreign body (intra-ocular) No contraindication to chemotherapy or surgery No other serious condition that would preclude study therapy No other uncontrolled medical condition, including any of the following: Thyroid disease Neuropsychiatric disease Infection Insufficient coronary capacity NYHA class III-IV heart disease No HIV positivity Not pregnant or nursing PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy, radiotherapy, or surgery for ipsilateral breast cancer No prior biopsy of tumor before MRI No MRI at another center within the past 15 days No participation in another investigational study of anticancer therapy within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: epirubicin hydrochloride|nan|
|Procedure: conventional surgery|nan|
|Procedure: dynamic contrast-enhanced magnetic resonance imaging|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: radiomammography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility and repeatability of MRI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of MRI vs mammogram |  |  | 
| MRI accuracy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer