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

Sponsor
Japanese Foundation for Cancer Research
Study ID
NCT04732598
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel + bevacizumab therapy — DRUG
    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
  • Paclitaxel + bevacizumab + atezolizumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 21, 2021
Status verified
Apr 2026
Primary completion
Sep 12, 2025
Completion
Mar 13, 2026

Study Design

Enrollment
281 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
  • Experimental: Arm B

Primary Outcome Measure

Progression-free Survival (investigator-assessed) [ Time Frame: Up to 2years after last patient enrolled ]

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