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

NCT ID: NCT02834494

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-22

Study Completion Date

2020-09-09

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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D Shear Wave Elastography (SWE)

Group Type OTHER

3D Shear Wave Elastography (SWE)

Intervention Type PROCEDURE

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.

Biopsy

Intervention Type BIOLOGICAL

Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.

Interventions

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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.

Intervention Type PROCEDURE

Biopsy

Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Curie Paris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IC 2015-07

Identifier Type: -

Identifier Source: org_study_id

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