Phase
Condition
Breast Cancer
Cancer
Treatment
Atezolizumab + Trastuzumab + Vinorelbine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female (Premenopausal or postmenopausal women)
- ECOG 0 to 2
- Histologically confirmed adenocarcinoma of the breast, metastatic or unresectablelocally 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
Exclusion Criteria:
- Treatment with any investigational anticancer drug within 14 days of the start ofstudy treatment.
- Patient has received Vinorelbine or any other vinca alkaloids previously immediatelyprior 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 tobrain metastases.
- Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 daysprior 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 orhypersensitivity.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamsterovary 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, organizingpneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), orevidence of active pneumonitis on screening chest CT scan. (Note: History of radiationpneumonitis 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 orimmune checkpoint targeting agents
- Treatment with systemic immunostimulatory agents (including but not limited tointerferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug priorto enrolment
- Treatment with systemic immunosuppressive medications within 2 weeks prior toenrolment, or anticipated requirement for systemic immunosuppressive medicationsduring the trial.
Study Design
Connect with a study center
H. Clínico San Cecilio de Granada
Granada, Andalucía
SpainActive - Recruiting
Institut Català d'Oncologia Hospitalet
Hospitalet de Llobregat, Barcelona
SpainActive - Recruiting
Hospital Universitario de Canarias
Tenerife, Islas Canarias 38320
SpainActive - Recruiting
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, La Coruña 15006
SpainActive - Recruiting
Comp. Hosp.Univ. Santiago (Chus)
Santiago De Compostela, La Coruña
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante,
SpainActive - Recruiting
Hospital Clinic de Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Universitari Vall d' Hebron
Barcelona,
SpainActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital San Pedro de Alcántara
Cáceres,
SpainActive - Recruiting
Hospital de León
León, 24071
SpainActive - Recruiting
Hospital Universitario 12 de octubre
Madrid,
SpainActive - Recruiting
Hospital Son Espases
Palma De Mallorca,
SpainActive - Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43201
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia,
SpainActive - Recruiting
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