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First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC — ATRACTIB  

Metastatic Breast Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate 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 (mTNBC)

Clinical Trial Description

Men and women age ≥ 18 years with previously untreated unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) that is not amenable to resection with curative intent regardless of programmed death-ligand 1 (PD-L1) status. The number of patients to be included is 100 patients. The primary objective is to evaluate the efficacy -in terms of progression-free survival (PFS)- of first line atezolizumab in combination with paclitaxel and bevacizumab (Avastin®) in patients with unresectable locally advanced or metastatic TNBC. After signing the ICF and confirmed eligibility, patients will begin treatment on 28 days cycles: Atezolizumab (840 mg) intravenously on days 1 and 15; Paclitaxel (90 mg/m2) via IV infusion on days 1, 8 and 15; Bevacizumab (Avastin® 10mg/kg) intravenously on days 1 and 15. Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Patients discontinuing the study treatment will enter a post- treatment follow-up period until death, withdrawal of consent, patient is lost to follow-up, or study termination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04408118
Study type Interventional
Source MedSIR
Contact
Status Completed
Phase Phase 2
Start date October 5, 2020
Completion date December 7, 2023
View Details
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