PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FIRST LINE ATEZOLIZUMAB IN COMBINATION WITH PACLITAXEL AND BEVACIZUMAB (AVASTIN®) IN PATIENTS WITH ADVANCED OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER - Phase II First Line Atezolizumab, PacliTaxel, and Bevacizumab (Avastin®) in mTNBC

MEDICA SCIENTIA INNOVATION RESEARCH, ARO0 sites100 target enrollmentOctober 21, 2020

ConditionsAdvanced or metastatic triple-negative breast cancer MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced or metastatic triple-negative breast cancer
Sponsor: MEDICA SCIENTIA INNOVATION RESEARCH, ARO
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 21, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MEDICA SCIENTIA INNOVATION RESEARCH, ARO

Eligibility Criteria

Inclusion Criteria

•1\. Signed ICF prior to participation in any study\-related activities
•2\. Male or female patients\=18 years at the time of signing ICF
•3\. Ability to comply with the study protocol, in the investigator's judgment
•4\. Histologically confirmed TNBC –regardless of PD\-L1 status– per ASCO/CAP criteria based on local testing on the most recent analyzed biopsy. Triple\-negative is defined as \<1% expression for ER and PgR as determined by IHC,and negative for HER2 (0–1\+ by immunohistochemistry \[IHC] or 2\+ and negative by ISH test)
•5\. Unresectable locally advanced or metastatic disease documented by CT scan or MRI that is not amenable to resection with curative intent
•6\. No prior chemotherapy and/or targeted therapy and/or immunotherapy and/or antiangiogenic agent for MBC. Patients who have received (neo)adjuvant taxane\-based chemotherapy and/or immunotherapy and/or an antiangiogenic agent are required to have a DFI of at least 12months after completion of each of these treatments. For (neo)adjuvant non\-taxane\-based chemotherapy, a DFI of at least 6months is required
•7\. Resolution of all acute toxic effects of prior anti\-cancer therapy to grade \= 1 as determined by the NCI\-CTCAE v.5\.0
•8\. Evidence of measurable disease or non\-measurable disease as per RECIST v.1\.1\. Patients with only bone lesions are also eligible
•9\. Willingness and ability to provide the most recent tumor biopsy since last progression from either metastatic or primary tissues at the time of the inclusion to perform exploratory studies. If not feasible, patient eligibility should be evaluated by a Sponsor's qualified designee. An additional tumor biopsy from either metastatic or primary (only if metastatic biopsies cannot be obtained for inaccessible lesion or subject safety concern) tissues would be collected at disease progression or study termination whenever it is feasible
•10\. ECOG Performance Status of 0 or 1

Exclusion Criteria

•\-Known active uncontrolled or symptomatic CNS metastases as indicated by clinical symptoms,cerebral edema,and/or progressive growth.Patients w/ a history of CNS metastases are eligible if meet following criteria:•Evidence of measurable disease or non\-measurable disease as per RECIST v.1\.1\.•Patient has no history of intracranial hemorrhage•Patient has not undergone stereotactic radiotherapy within 7days prior to initiation of study treatment, whole\-brain radiotherapy within 14days prior to initiation of study treatment, or neurosurgical resection within 28days prior to initiation of study treatment•Patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted
•\-History of leptomeningeal disease
•\-Uncontrolled tumor\-related pain
•\-Active or history of autoimmune disease or immune deficiency
•\-Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•\-Uncontrolled or symptomatic hypercalcemia (ionized calcium\>1\.5mmol/L; calcium\>12mg/dL)
•\-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug\-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
•\-Active tuberculosis
•\-Significant cardiovascular disease 6months prior to initiation of study treatment. These include New York Heart Association Class II or greater cardiac disease, myocardial infarction, unstable arrhythmia, or unstable angina, symptomatic pericarditis, ventricular arrhythmias –except for benign premature ventricular contractions, arrhythmias or conduction abnormalities requiring a pacemaker or not controlled with medication, and prior peripheral vascular disease including any cerebrovascular accident including transient ischemic attack, any pulmonary embolism, any prior deep vein thrombosis, and/or any grade \=2 peripheral vascular disease
•\-LVEF\<50% as determined by MUGA scan or ECHO