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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D Shear Wave Elastography (SWE)
Biopsy
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Neoplasms focused on measuring locally advanced breast cancer, neoadjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Curie Paris

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3D Shear Wave Elastography (SWE)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)
Use technic Supersonic Shear Imaging.
peritumoral environmental elasticity properties
Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
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.
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
Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine
Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score
Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity
Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"
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.

Full Information

First Posted
July 8, 2016
Last Updated
December 10, 2020
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02834494
Brief Title
Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave),
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
locally advanced breast cancer, neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D Shear Wave Elastography (SWE)
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
3D Shear Wave Elastography (SWE)
Intervention Description
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
Biological
Intervention Name(s)
Biopsy
Intervention Description
Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
Primary Outcome Measure Information:
Title
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
Description
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).
Time Frame
up to 32 months
Secondary Outcome Measure Information:
Title
Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)
Description
Use technic Supersonic Shear Imaging.
Time Frame
up to 32 months
Title
peritumoral environmental elasticity properties
Description
Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
Time Frame
up to 32 months
Title
Reliable early biomarker of histological response.
Description
Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response.
Time Frame
up to 32 months
Title
tumor volume changes under treatment by 3D ultrasound
Description
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
Time Frame
up to 32 months
Title
Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine
Time Frame
up to 32 months
Title
Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
Time Frame
up to 32 months
Title
Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score
Time Frame
up to 32 months
Title
Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity
Time Frame
up to 32 months
Title
Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"
Time Frame
up to 32 months
Title
Compare tumor elasticity to conventional histological parameters
Description
For the additional biopsy (optional) under neoadjuvant chemotherapy at T2, correlation elastography to pathological parameters of peritumoral environment by analyzing conventional histological parameters.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institut Curie Paris
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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