Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00462696
First received: April 18, 2007
Last updated: May 12, 2011
Last verified: December 2008

April 18, 2007
May 12, 2011
February 2006
May 2011   (final data collection date for primary outcome measure)
Reproducibility and repeatability of MRI [ Designated as safety issue: No ]
Reproducibility and repeatability of MRI
Complete list of historical versions of study NCT00462696 on ClinicalTrials.gov Archive Site
  • Results of MRI vs mammogram [ Designated as safety issue: No ]
  • MRI accuracy [ Designated as safety issue: No ]
Results of MRI vs mammogram
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00462696
CDR0000540537, IB-2005-37, INCA-RECF0144, IB-ISNA
Not Provided
Not Provided
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