Condition: HR+/HER2-negative Breast Cancer · Sponsor: Totus Medicines
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are: 1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2? 2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? 3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)
This description comes directly from the study's public registry record.
Clinical Trials · Please e-mail · clinicaltrials@totusmedicines.com
Always discuss trial participation with your own doctor first.
| Northwestern Memorial Hospital | Chicago, Illinois, United States | Recruiting |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| Sarah Cannon Cancer Center | Nashville, Tennessee, United States | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee, United States | Recruiting |
| Texas Oncology - Flower Mound | Flower Mound, Texas, United States | Recruiting |
| Virginia Cancer Specialists | Fairfax, Virginia, United States | Recruiting |
| NEXT Oncology - Hospital Quironsalud Barcelona - PPDS | Barcelona, Spain | Recruiting |
| START Barcelona HM Nou Delfos | Barcelona, Spain | Recruiting |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Barcelona, Spain | Recruiting |
+ 6 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05683418