The Phase 3 AMBITION study (NCT04732598), investigating atezolizumab in combination with bevacizumab and paclitaxel for locally advanced unresectable or metastatic hormone receptor-positive HER2-negative breast cancer, reached its primary completion on 2025-09-12. This milestone indicates the completion of data collection for the primary outcome measures of the trial.

Background

The AMBITION trial (JCOG1919E) focuses on locally advanced unresectable or metastatic hormone receptor-positive HER2-negative breast cancer. This type of breast cancer is characterized by the presence of hormone receptors and the absence of HER2 protein overexpression, influencing treatment strategies.

Trial design

The AMBITION study (NCT04732598) is a Phase 3, randomized, open-label trial. It enrolled 281 participants with hormone receptor-positive HER2-negative metastatic breast cancer. The study's objective is to evaluate the efficacy and safety of a combination therapy. Participants were randomized to receive either paclitaxel and bevacizumab, or paclitaxel, bevacizumab, and atezolizumab.

What this means

The primary completion of the AMBITION trial signifies that all planned data collection for the primary endpoints has concluded. Researchers will now proceed with data analysis to determine the efficacy and safety profile of atezolizumab in combination with bevacizumab and paclitaxel for the studied breast cancer population. The results are anticipated to provide crucial insights into potential new treatment options for patients with locally advanced unresectable or metastatic hormone receptor-positive HER2-negative breast cancer.

Source

The information regarding the primary completion of this trial was obtained from the ClinicalTrials.gov database, a public resource for clinical study information. The study record for NCT04732598, titled "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," was updated on 2025-09-12 on clinicaltrials.gov.