Clinical trial NCT02834494: Assessment of Response to Neo-adjuvant Chemotherapy for Patients With a Locally Advanced Breast Cancer With 3D Elastography (Shear Wave),
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: locally advanced breast cancer
neoadjuvant chemotherapy
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Assess the accuracy of the sequential measurements by 3D Shear Wave Elastography (SWE) for predicting histological response to neoadjuvant chemotherapy
timeFrame: up to 32 months
Secondary outcomes:
measure: Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)
timeFrame: up to 32 months
measure: peritumoral environmental elasticity properties
timeFrame: up to 32 months
measure: Reliable early biomarker of histological response.
timeFrame: up to 32 months
measure: tumor volume changes under treatment by 3D ultrasound
timeFrame: up to 32 months
measure: Compare changes in tumor elasticity under chemotherapy to variables obtained by other imaging modalities (Breast MRI) performed in clinical routine
timeFrame: up to 32 months
measure: Compare changes in tumor elasticity under neoadjuvant chemotherapy to changes in diffusion apparent coefficient by using technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).
timeFrame: up to 32 months
measure: Compare changes in tumor volume to histological response (Gold Standard : surgery after neoadjuvant chemotherapy according to " Residual Cancer Burden " score
timeFrame: up to 32 months
measure: Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity
timeFrame: up to 32 months
measure: Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"
timeFrame: up to 32 months
measure: Compare tumor elasticity to conventional histological parameters
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Paris
Study officials:
References: