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

Breast Neoplasms Clinical Trial

— NEO-ELASTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834494
• Other study ID #: IC 2015-07 NEOELASTO
• Status: Completed
• Phase: N/A
• Start date: February 22, 2016
• Est. completion date: September 9, 2020

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• 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.

Biological:
• Biopsy
Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.

Locations

Country	Name	City	State
France	Institut Curie Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	peritumoral environmental elasticity properties	Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).	up to 32 months
Secondary	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
Secondary	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
Secondary	Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine		up to 32 months
Secondary	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
Secondary	Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score		up to 32 months
Secondary	Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity		up to 32 months
Secondary	Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"		up to 32 months
Secondary	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