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Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
Sponsor: SOLTI Breast Cancer Research Group
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
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