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Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer
Bu çalışma, HER2 pozitif ilerlemiş/metastatik meme kanseri (breast cancer) olan hastalarda Atezolizumab, Trastuzumab ve Vinorelbine ilaçlarının birlikte kullanımını değerlendirmektedir. Çalışmaya, en az Trastuzumab ve diğer anti-HER2 tedavileri almış, ölçülebilir hastalığı olan hastalar katılabilmektedir. Çalışma Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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 trastuzumab and other anti-HER2 ADCs (including but not limited to T-DM1). * Measurable disease according to RECIST 1.1 criteria. * Adequate organ function * Baseline LVEF ≥50% * Participants with asymptomatic brain metastases are eligible. 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 immediately prior to initiate study treatment. * History of other malignant tumors in the past 3 years * Known or suspected leptomeningeal disease (LMD)/ poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases. * 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.