Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
18 Years
70 Years
Female
Breast Cancer
Trial Information
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Diagnostic
Outcome Measure:
Reproducibility and repeatability of MRI
Safety Issue:
No
Principal Investigator
Fabienne Valentin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
United States: Federal Government
Study ID:
CDR0000540537
NCT ID:
NCT00462696
Start Date:
February 2006
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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