Clinical trial · Observational
Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer
Early Assessment of Shear Wave Elastography Parameters to Assess the Response to Neoadjuvant Chemotherapy in Patients With Invasive Breast Cancer
NCT05068999CI-TRIAL-00055700unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| shear wave elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- shear wave elastography assessment in patients with invasive breast cancer.
- timeFrame
- from october 2021 to october2022
- description
- measurement of shear wave elastography parameters in patients with invasive breast cancer before and after neoadjuvant chemotherapy and assess the residual cancer burden for each patient.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * • Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Age ≥18 * Eastern Cooperative Oncology Group performance status ≤1 * Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l) * Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal) * Adequate renal function (creatinine clearance \>50 ml/min) * LVEF ≥50% measured by echocardiography or MUGA * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Absence of any medical condition that would place the patient at unusual risk. * Signed written informed consent Exclusion Criteria: * • previous radiation therapy or chemotherapy * Other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection. * Evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures. * Evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast. * Concurrent anti-cancer treatment or another investigational drug.
References
Publications (32)
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- BACKGROUNDPerou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093. PMID 10963602
- BACKGROUNDHu Z, Fan C, Oh DS, Marron JS, He X, Qaqish BF, Livasy C, Carey LA, Reynolds E, Dressler L, Nobel A, Parker J, Ewend MG, Sawyer LR, Wu J, Liu Y, Nanda R, Tretiakova M, Ruiz Orrico A, Dreher D, Palazzo JP, Perreard L, Nelson E, Mone M, Hansen H, Mullins M, Quackenbush JF, Ellis MJ, Olopade OI, Bernard PS, Perou CM. The molecular portraits of breast tumors are conserved across microarray platforms. BMC Genomics. 2006 Apr 27;7:96. doi: 10.1186/1471-2164-7-96.