Phase IbII Study Evaluating Multiple Treatment Combinations for Women With Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

What this Trial Is About

Researchers are investigating multiple treatment combinations in participants with inoperable, locally advanced, or metastatic breast cancer. This Phase IbII, open-label, multicenter, randomized umbrella study focuses on three cohorts of estrogen receptor-positive ER breast cancer patients, including HER2-negative and HER2-positive subtypes, who have shown disease progression after prior therapies like CDK46 inhibitors or anti-HER2 treatments. The study is designed to adapt by adding or closing treatment arms based on clinical activity and safety. Participants receive different drug combinations depending on their cohort and treatment arm. Treatments include oral medications such as giredestrant, abemaciclib, ipatasertib, inavolisib, ribociclib, everolimus, samuraciclib, and palbociclib, as well as subcutaneous and intravenous therapies like pertuzumab and trastuzumab fixed-dose combination PH FDC SC and atezolizumab. Dosing schedules vary, with cycles lasting 21 or 28 days, continuing until unacceptable toxicity or disease progression. Some arms include combinations of these drugs tailored to specific tumor characteristics, such as PIK3CA mutations or estrogen receptor mutations. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST v1.1 criteria to evaluate response, monitoring for adverse events, and cardiac function tests. Researchers track outcomes such as objective response, progression-free survival, disease control, clinical benefit rate, overall survival, and duration of response for up to six years. Safety is monitored up to 30 days after the last dose. Tumor specimens and blood samples are collected for biomarker evaluation. The study aims to gather comprehensive data on the efficacy and safety of these treatment combinations over an extended period.

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer