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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)

I

Institut Curie

Status

Completed

Conditions

Breast Neoplasms

Treatments

Procedure: 3D Shear Wave Elastography (SWE)
Biological: Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02834494
IC 2015-07 NEOELASTO

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

140 participants in 1 patient group

3D Shear Wave Elastography (SWE)
Other group
Treatment:
Biological: Biopsy
Procedure: 3D Shear Wave Elastography (SWE)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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