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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
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Drug: docetaxel
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: neoadjuvant therapy
Procedure: radiomammography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Diagnostic
Official Title: Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Reproducibility and repeatability of MRI [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Results of MRI vs mammogram [ Designated as safety issue: No ]
  • MRI accuracy [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2006
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462696

Locations
France
Institut Bergonie
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: Fabienne Valentin, MD Institut Bergonié
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00462696     History of Changes
Other Study ID Numbers: CDR0000540537, IB-2005-37, INCA-RECF0144, IB-ISNA
Study First Received: April 18, 2007
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
 Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013