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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)

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ClinicalTrials.gov Identifier: NCT02834494
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: 3D Shear Wave Elastography (SWE) Biological: Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : February 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
3D Shear Wave Elastography (SWE) 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834494


Contacts
Contact: Delphine SEBBAG-SFEZ, MD 33+(1) 56 24 55 89 delphine.sebbagsfez@curie.fr

Locations
France
Institut Curie Paris Recruiting
Paris, France, 75005
Principal Investigator: Delphine SEBBAG-SFEZ, MD         
Sponsors and Collaborators
Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02834494     History of Changes
Other Study ID Numbers: IC 2015-07
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Curie:
locally advanced breast cancer
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases