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NCT Number: NCT02834494

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie Paris

Paris, 75005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D Shear Wave Elastography (SWE)

Procedure

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.

Biopsy

Biological

Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Elastic properties before treatment (especially ratio between tumor and glandular breast or fat tissues close to the tumors)

    Time frame: up to 32 months

    Use technic Supersonic Shear Imaging.

  2. peritumoral environmental elasticity properties

    Time frame: up to 32 months

    Use technic Supersonic Shear Imaging (Explorer, Supersonic Imagine).

  3. Reliable early biomarker of histological response.

    Time frame: up to 32 months

    Estimate under chemotherapy if early changes in tumor's elasticity can provide a reliable early biomarker of histological response.

  4. tumor volume changes under treatment by 3D ultrasound

    Time frame: 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

  5. 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

  6. 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

  7. 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

  8. Compare predictive value (semi-quantitative et quantitative measurements) of tumor elasticity

    Time frame: up to 32 months

  9. Assess vascular shape and its evolution under treatment by Ultrasensitive Doppler technic "Ultra-Fast Doppler"

    Time frame: up to 32 months

  10. Compare tumor elasticity to conventional histological parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: NEO-ELASTO

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2016
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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