Status:
COMPLETED
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
Lead Sponsor:
Institut Bergonié
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
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. Dru...
Detailed Description
Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00462696
Start Date
February 1 2006
End Date
December 31 2008
Last Update
October 6 2025
Active Locations (1)
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1
Institut Bergonie
Bordeaux, France, 33076