N/A Completed N=16 Diagnostic

MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer

Breast Cancer

Source: ClinicalTrials.gov NCT00462696 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Sep 2025

Primary outcomePrimary: Reproducibility of the MRI Vascular Permeability (Kep)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Reproducibility of the MRI Vascular Permeability (Kep)	—	—
PRIMARY Reproducibility of the MRI Vascular Permeability (HA)	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00462696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.