Clinical trial · Interventional
Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), NEOELASTO
3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.
NCT02834494CI-TRIAL-00097854NEO-ELASTOcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy in patients with locally advanced 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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Shear Wave Elastography (SWE) | Procedure | — | UNRESOLVED |
| Biopsy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 3D Shear Wave Elastography (SWE)
- interventionNames
- Procedure: 3D Shear Wave Elastography (SWE)
- Biological: Biopsy
Primary outcomes (1)
- measure
- Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
- timeFrame
- up to 32 months
- description
- Measure of the tumor prior to neoadjuvant chemotherapy (T0), at T1 and T2(1stand 2nd courses of anthracycline), at mid-treatment between anthracycline and taxane chemotherapy (Tmi), at the end of chemotherapy before surgery (Tfin).
Secondary outcomes (10)
- measure
- Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Infiltrating Breast Cancer untreated and/or locally advanced (stages I (T1c), IIa IIb, IIIa, IIIb, IIIc of UICC classification), whatever histological type. * Neo-adjuvant chemotherapy decided.(Anthracyclines, taxanes and, for tumors overexpressing human epidermal growth factor receptor 2 (HER2) protein, targeted recombinant humanized monoclonal antibodies) * Index tumor whose dimensions are between 10 to 50 mm. Multifocality, and/or multicentricity and/or bilaterality accepted (maximum 2 tumors by breast et tumors well differentiated from each other). * Patients aged at least 18 years old at diagnosis * Full results conventional breast exams available and no reason to achieve MRI breast exam * Patient explanation given and consent information signed Exclusion Criteria: * Pregnant or during lactation * Personal history of ipsilateral breast cancer (ipsilateral recurrence or second cancer in the same breast). * Patient carrier of cosmetic breast implants * Person deprived of liberty or under guardianship * Contraindication for receiving neo-adjuvant chemotherapy for any medical reason * Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
References
Publications (0)
Data not yet available
No reference posted for this study.