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 S. L. (MedSIR)0 sites100 target enrollmentJuly 20, 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 Avastin Sindaxel Actavis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced or metastatic triple-negative breast cancer
Sponsor: Medica Scientia Innovation Research S. L. (MedSIR)
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 20, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medica Scientia Innovation Research S. L. (MedSIR)

Eligibility Criteria

Inclusion Criteria

•1\. Signed informed consent form (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 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple\-negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PgR) as determined by immunohistochemistry (IHC),and negative for HER2 (0–1\+ by immunohistochemistry \[IHC] or 2\+ and negative by in situ hybridization \[ISH] test)
•5\. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (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 disease\-free interval (DFI) of at least 12 months after completion of each of these treatments. For (neo)adjuvant non\-taxane\-based chemotherapy, a DFI of at least 6 months 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 (except for alopecia, grade \= 2 peripheral neuropathy, or other toxicities not considered a safety risk for the patient at investigator's discretion)
•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\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria

•1\. Known active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases are eligible if they meet the following criteria:
•Evidence of measurable disease or non\-measurable disease as per RECIST v.1\.1\.
•The patient has no history of intracranial hemorrhage.
•The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole\-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
•The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.
•2\. History of leptomeningeal disease.
•3\. Uncontrolled tumor\-related pain.
•4\. Active or history of autoimmune disease or immune deficiency
•5\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
•Note: Patients with indwelling catheters (e.g., PleurX®) are allowed.