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

NCT02834494 | Completed

• 1 other identifier: IC 2015-07
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Neoplasms

Keywords

locally advanced breast cancer; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)

  up to 32 months

• peritumoral environmental elasticity properties

  up to 32 months

• Reliable early biomarker of histological response.

  up to 32 months

• tumor volume changes under treatment by 3D ultrasound

  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

Study Arms (1)

3D Shear Wave Elastography (SWE)

OTHER

Procedure: 3D Shear Wave Elastography (SWE); Biological: Biopsy

Interventions

3D Shear Wave Elastography (SWE) 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.

3D Shear Wave Elastography (SWE)

Biopsy BIOLOGICAL

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

3D Shear Wave Elastography (SWE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie Paris

Paris, 75005, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 15, 2016
• Study Start: February 22, 2016
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (1)