Clinical trial · Interventional
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Woment treated with neoadjuvant chemotherapy for breast cancer
- description
- The patient will be recruited during a multidisciplinary team meeting (MDT) involving a medical oncologist, radiation oncologist, and surgeon. The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma.
- interventionNames
- Drug: Neoadjuvant chemotherapy
Primary outcomes (2)
- measure
- Reproducibility of the MRI Vascular Permeability (Kep)
- timeFrame
- two months after start of neoadjuvant chemotherapy
- description
- MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma). Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 daysReferences
Publications (0)
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