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Spots Global Cancer Trial Database for A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

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Trial Identification

Brief Title: A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Official Title: A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Study ID: NCT04610528

Conditions

Breast Cancer

Interventions

U3 1402
U3 1402

Study Description

Brief Summary: This is a prospective, multicenter, single arm, window-of-opportunity study evaluating the biological effect of U3-1402 in treatment naïve patients with early breast cancer, whose primary tumors are ≥1 cm by ultrasound evaluation. The primary objective is to evaluate the biological activity of U3-1402, measured as the CelTIL score increase at post-treatment (C1D21) in HR+/HER2-negative BC included patients. The study will consist of 2 parts enrolling \~115 patients. * Part A will target to treat, with 6.4 mg/kg dose, 80 patients with HR-positive/HER2-negative tumors and * Part B will target to treat with 5.6 mg/kg dose 20 patients with HR-positive/HER2-negative and 15 patients with TNBC tumors Part A will test U3-1402 in patients with HR-positive/HER2-negative early breast cancer with a dose of 6.4 mg/kg. Part B will consist in testing 5.6 mg/kg dose of U3-1402 in patients with HR-positive/HER2-negative early breast cancer and in triple-negative early breast cancer and will be performed sequentially after Part A.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

ICO Badalona, Badalona, Barcelona, Spain

Institut Català d'Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Canarias, Tenerife, Islas Canarias, Spain

Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain

Hospital Universitari Vall d'Hebrón, Barcelona, , Spain

Hospital Clínic de Barcelona, Barcelona, , Spain

Centro Integral Oncológico Clara Campal (CIOCC), Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario Virgen del Rocio, Sevilla, , Spain

Hospital Clinico Universitario de Valencia, Valencia, , Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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