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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462696
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : May 13, 2011
Information provided by:
National Cancer Institute (NCI)

April 18, 2007
April 19, 2007
May 13, 2011
February 2006
May 2011   (Final data collection date for primary outcome measure)
Reproducibility and repeatability of MRI
Same as current
Complete list of historical versions of study NCT00462696 on Archive Site
  • Results of MRI vs mammogram
  • MRI accuracy
Results of MRI vs mammogram
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MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative 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.



  • 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.

Not Applicable
Allocation: Non-Randomized
Primary Purpose: Diagnostic
Breast Cancer
  • Drug: docetaxel
  • Drug: epirubicin hydrochloride
  • Procedure: conventional surgery
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
  • Procedure: neoadjuvant therapy
  • Procedure: radiomammography
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
Not Provided
May 2011   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Institut Bergonié
Not Provided
Study Chair: Fabienne Valentin, MD Institut Bergonié
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP