NCT04408118

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Metastatic Breast Cancer
• Advanced Breast Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab (840 mg) will be administered intravenously on Days 1 and 15. The first infusion of atezolizumab will be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
DRUG	Paclitaxel	Will be administered on days 1, 8 and 15 via IV infusion over 1 hour.
DRUG	Bevacizumab	Will be administered intravenously over 30-90 minutes on Days 1 and 15.

Timeline

• Start date: 2020-10-05
• Primary completion: 2023-12-07
• Completion: 2023-12-07
• First posted: 2020-05-29
• Last updated: 2024-06-04

Locations

26 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom