A Single Arm Phase 1/2 Trial of Abemaciclib + Avutometinib (VS-6766) + Fulvestrant in Metastatic HR+/HER2- Breast Cancer
Adrienne G. Waks
Summary
This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+/HER2-negative breast cancer. The names of the study drugs involved in this study are: * VS-6766 * Abemaciclib * Fulvestrant
Description
This is single-arm open-label phase 1/2 trial assessing the safety and efficacy of the new drug, VS-6766, plus abemaciclib and fulvestrant in treating metastatic hormone receptor-positive and HER2-negative (HR+/HER2-) breast cancer. VS-6766 is a unique small molecule drug that targets and interrupts a pathway that allows cancer cells to grow.The U.S. Food and Drug Administration (FDA) has not approved VS-6766 as a treatment for any disease. The FDA has approved abemaciclib and fulvestrant as a treatment option for breast cancer. The study is divided into three study periods: a screening peri…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. * Participants may have measurable or non-measurable disease according to RECIST v1.1. * Men and pre- a…
Interventions
- DrugVS-6766
Taken Orally
- DrugAbemaciclib
Taken Orally
- DrugFulvestrant
Administered by intramuscular injection
Locations (3)
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstititeBoston, Massachusetts