Breast NeoplasmsNEO-ELASTONCT02834494
Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave), NEOELASTO
A study testing 3D Shear Wave Elastography (SWE) and Biopsy in people with Breast Neoplasms, run by Institut Curie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- 3D Shear Wave Elastography (SWE) and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2016to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- 3D Shear Wave Elastography (SWE), Biopsy
- Keywords
- locally advanced breast cancer, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Shear Wave Elastography (SWE)Procedure or surgery
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.
BiopsyBiological
Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
| Study group | Role | What they receive |
|---|---|---|
| 3D Shear Wave Elastography (SWE) | Other | Not described Receives: Procedure: 3D Shear Wave Elastography (SWE); Biological: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Use technic Supersonic Shear Imaging.
Measured: up to 32 months
peritumoral environmental elasticity properties
Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
Measured: up to 32 months
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.
Measured: up to 32 months
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
Measured: up to 32 months
Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine
Measured: up to 32 months
Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
Measured: up to 32 months
Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score
Measured: up to 32 months
Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity
Measured: up to 32 months
Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"
Measured: up to 32 months
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start22 Feb 2016
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834494
- Sponsor's protocol ID
- IC 2015-07
- Acronym
- NEO-ELASTO
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2016
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02834494
- Acronym / sponsor ID
- NEO-ELASTO / IC 2015-07
- Conditions
- Breast Neoplasms
- Keywords
- locally advanced breast cancer, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Shear Wave Elastography (SWE) | Other | Procedure: 3D Shear Wave Elastography (SWE), Biological: Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 3D Shear Wave Elastography (SWE) |
| BiopsyOptional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline. | Biological | 3D Shear Wave Elastography (SWE) |
Primary outcome
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
Time frame: 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).
10 secondary outcomes
Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)
Time frame: up to 32 months
peritumoral environmental elasticity properties
Time frame: up to 32 months
Reliable early biomarker of histological response.
Time frame: up to 32 months
tumor volume changes under treatment by 3D ultrasound
Time frame: up to 32 months
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
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
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
Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity
Time frame: up to 32 months
Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"
Time frame: up to 32 months
Compare tumor elasticity to conventional histological parameters
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Shear Wave Elastography (SWE) and Biopsy in people with Breast Neoplasms, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy (time frame: up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.