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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Procedure: 3D Shear Wave Elastography (SWE); Biological: Biopsy

• Registration Number: NCT02834494
• Lead Sponsor: Institut Curie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-22
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-15
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D Shear Wave Elastography (SWE)	3D Shear Wave Elastography (SWE)	-
3D Shear Wave Elastography (SWE)	Biopsy	-

Primary Outcome Measures

Name	Time	Method
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy	up to 32 months	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 Outcome Measures

Name	Time	Method
tumor volume changes under treatment by 3D ultrasound	up to 32 months	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
Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine	up to 32 months
Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)	up to 32 months	Use technic Supersonic Shear Imaging.
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 tumor elasticity to conventional histological parameters	6 weeks	For the additional biopsy (optional) under neoadjuvant chemotherapy at T2, correlation elastography to pathological parameters of peritumoral environment by analyzing conventional histological parameters.
Reliable early biomarker of histological response.	up to 32 months	Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response.
peritumoral environmental elasticity properties	up to 32 months	Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
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

Trial Locations

Locations (1)

Institut Curie Paris; 🇫🇷 Paris, France