Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave),

Study Overview
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Brief Summary
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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.

Official Title
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3D Elastography (Shear Wave) : Assessment of Response to Neo-adjuvant Chemotherapy (NACT) : in Vivo Quantification, for Patients With a Locally Advanced Breast Cancer.

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: 3D Shear Wave Elastography (SWE)
* Biological: Biopsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3D Shear Wave Elastography (SWE)<br> | Procedure: 3D Shear Wave Elastography (SWE)<br>* Ultrasound imaging with Elastography will be performed at the inclusion (T0), after course 1 and course 2 respectively with anthracyclines, at the end of anthracycline treatment and at the end of taxane treatment.<br>Biological: Biopsy<br>* Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy | 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). | up to 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors) | Use technic Supersonic Shear Imaging. | up to 32 months | 
| peritumoral environmental elasticity properties | Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine). | up to 32 months | 
| Reliable early biomarker of histological response. | Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response. | up to 32 months | 
| tumor volume changes under treatment by 3D ultrasound | Estimate tumor volume changes under treatment by 3D ultrasound and Compare with measurements obtained by other conventional imaging methods currently used for monitoring patients under neoadjuvant chemotherapy | up to 32 months | 
| Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine |  | up to 32 months | 
| Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine). |  | up to 32 months | 
| Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to  Residual Cancer Burden  score |  | up to 32 months | 
| Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity |  | up to 32 months | 
| Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic Ultra-Fast Doppler |  | up to 32 months | 
| Compare tumor elasticity to conventional histological parameters | For the additional biopsy (optional) under neoadjuvant chemotherapy at T2, correlation elastography to pathological parameters of peritumoral environment by analyzing conventional histological parameters. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced breast cancer, neoadjuvant chemotherapy