NCT04732598

A Phase III Study of Bevacizumab and Paclitaxel in Combination with Atezolizumab As a Treatment for Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer

A Phase III, Randomized Study of Bevacizumab and Paclitaxel in Combination with Atezolizumab As a Treatment for Patients with Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Japanese Foundation for Cancer Research · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel + bevacizumab therapy	The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met. \[Paclitaxel\] 90mg/m\^2, day1,8,15, IV \[Bevacizumab\] 10mg/kg, day1,15, IV
DRUG	Paclitaxel + bevacizumab + atezolizumab	The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met. \[Atezolizumab\] 840 mg/body, day 1,15, IV \[Paclitaxel\] 90mg/m\^2, day1,8,15, IV \[Bevacizumab\] 10mg/kg, day1,15, IV

Timeline

• Start date: 2021-01-21
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2021-02-01
• Last updated: 2025-02-05

Locations

1 site across 1 country: Japan