Phase IbII Study Testing Multiple Treatment Combinations for Metastatic or Locally Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of multiple treatment combinations in people with metastatic or locally advanced breast cancer. This umbrella study includes several groups based on specific breast cancer types and prior treatments, such as triple-negative breast cancer with PD-L1 positivity and hormone receptor-positive, HER2-negative or HER2-low disease with PIK3CA mutations. The study is divided into two stages, with the second stage allowing certain participants to continue treatment if their disease progresses or side effects occur. Participants receive different combinations of drugs depending on their group. Treatments include various chemotherapy drugs, immunotherapies like atezolizumab, targeted therapies such as inavolisib, and other agents given orally or intravenously in cycles lasting 21 or 28 days. Some participants may switch to alternative treatment combinations during the second stage if their disease worsens or they experience side effects while meeting eligibility criteria. Throughout the study, participants undergo regular assessments including imaging to measure tumor size according to RECIST v1.1 criteria and laboratory tests to monitor health and side effects. The main outcome measured is the objective response rate from baseline until disease progression or loss of clinical benefit, which may be observed for up to approximately 12 years. Secondary outcomes include progression-free survival, disease control rate, overall survival, duration of response, and the frequency of adverse events. Treatment continues until unacceptable toxicity or disease progression occurs.

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer