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

  • STATUS
    Recruiting
  • End date
    Feb 24, 2025
  • participants needed
    110
  • sponsor
    SOLTI Breast Cancer Research Group
Updated on 25 March 2021

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

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Atezolizumab + Trastuzumab + Vinorelbine
Clinical Study IdentifierNCT04759248
SponsorSOLTI Breast Cancer Research Group
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female (Premenopausal or postmenopausal women)
ECOG 0 to 2
Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced
All patients must have received at least pertuzumab/trastuzumab and T-DM1
Measurable disease according to RECIST 1.1 criteria
Adequate organ function
Baseline LVEF 50%

Exclusion Criteria

Treatment with any investigational anticancer drug within 14 days of the start of study treatment
Patient has received Vinorelbine or any other vinca alkaloids previously
History of other malignant tumors in the past 3 years
Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion
Cardiopulmonary dysfunction
Any other severe, uncontrolled
Major surgery in the 28 days prior to enrolment
Infection with HIV or active Hepatitis B and/or Hepatitis C
History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field [fibrosis] is permitted.)
Active tuberculosis
Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment
Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug prior to enrolment
Treatment with systemic immunosuppressive medications within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial
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