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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

NCT04732598 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2026-04-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • Japanese Foundation for Cancer Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2025-09-12
Completion
2026-03-13

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732598 on ClinicalTrials.gov