Clinical trial

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

Name
IC 2015-07 NEOELASTO
Description
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.
Trial arms
Trial start
2016-02-22
Estimated PCD
2020-09-09
Trial end
2020-09-09
Status
Completed
Treatment
3D Shear Wave Elastography (SWE)
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.
Arms:
3D Shear Wave Elastography (SWE)
Biopsy
Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
Arms:
3D Shear Wave Elastography (SWE)
Size
140
Primary endpoint
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
up to 32 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

1 product

1 indication

Organization
Institut Curie
Product
Biopsy