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NCT04759248
PHASE2

Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer

Sponsor: SOLTI Breast Cancer Research Group

View on ClinicalTrials.gov

Summary

Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed. Response following anti-PD1/PD-L1 monotherapy is associated with large survival benefit in the advanced setting. Previous studies of the intrinsic subtypes have shown that Basal-like and HER2-E are associated with higher expression of immune-related genes or higher infiltration of stromal tumor infiltrating lymphocytes compared to the luminal subtypes. Immune infiltration in BC is associated with chemo/antiHER2 responsiveness and potentially benefit from anti-PD-1/PD-L1 inhibitors. In addition, one emerging biomarker of response to anti-PD-1 therapy is the tumor mutational burden (I.e. the total number of mutations per coding area of a tumor genome). The HER2-E and Basal-like profiles have been associated with high mutational burden. A range of studies have been initiated including several phase II/III studies evaluating atezolizumab in combination with different chemotherapeutic compounds routinely used in breast cancer, but none with predefined biomarker beyond the expression of PD-L1 by IHC

Official title: A Phase II With 2 Parallel Cohorts Clinical Trial Targeting Estrogen Receptor Negative or PAM50 Non-luminal Disease With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer - ATREZZO Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2021-03-15

Completion Date

2027-07-01

Last Updated

2025-09-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Atezolizumab + Trastuzumab + Vinorelbine

* Atezolizumab IV 1200 mg in combination with * Trastuzumab sc 600mg or IV 6mg/kg every 3 weeks and * Vinorelbine 25 mg/m² IV or 60 mg/m2 PO on days 1 and 8, every 3 weeks during the first cycle and if there are no toxicity signs dose will be increased to 80 mg/m2 PO o 30 mg/m2 IV.

Locations (15)

H. Clínico San Cecilio de Granada

Granada, Andalusia, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Institut Català d'Oncologia Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, La Coruña, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Spain

Hospital San Pedro de Alcántara

Cáceres, Spain

Hospital de León

León, Spain

Hospital Universitario 12 de octubre

Madrid, Spain

Hospital Son Espases

Palma de Mallorca, Spain

Hospital Universitari Sant Joan de Reus

Reus, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain