Back to resultsMRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
docetaxel
epirubicin hydrochloride
conventional surgery
dynamic contrast-enhanced magnetic resonance imaging
neoadjuvant therapy
radiomammography
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility 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
Sites / Locations
- Institut Bergonie
Outcomes
Primary Outcome Measures
Reproducibility and repeatability of MRI
Secondary Outcome Measures
Results of MRI vs mammogram
MRI accuracy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00462696
Brief Title
MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
Official Title
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Bergonié
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
radiomammography
Primary Outcome Measure Information:
Title
Reproducibility and repeatability of MRI
Secondary Outcome Measure Information:
Title
Results of MRI vs mammogram
Title
MRI accuracy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne Valentin, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Learn more about this trial
MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer
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