Spots Global Cancer Trial Database for VS-6766+Abema+Fulv in Met HR+/HER- BC

Study Description

Brief 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

Detailed 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 period; a treatment period; and a post-treatment follow-up period. Participants will receive study treatment for as long there are no serious side effects and the disease does not get worse. It is expected that about 63 people will take part in this research study. Verastem Oncology, a biopharmaceutical company, is supporting this research study by providing VS-6766 and funding to conduct this trial. Eli Lilly, a pharmaceutical company, is supporting this research study by providing the drug, abemaciclib.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial