What is the Purpose of this Study?
This study focuses on people who have metastatic (spread to other areas of the body) hormone receptor-positive, human epidermal growth factor 2-negative (HR+/HER2-) breast cancer that has a mutation in a gene called PIK3CA. The purpose of the study is to learn about the effectiveness and safety of an experimental drug called RLY-2608 in combination with another drug, fulvestrant, compared to the drug capivasertib in combination with fulvestrant. Researchers also aim to evaluate the efficacy and safety of RLY-2608 combined with fulvestrant, compared to capivasertib combined with fulvestrant. RLY-2608 is a mutation-specific PIK3CA inhibitor which shows promising efficacy and less off-tumor, on-target toxicities. Capivasertib is a standard-of-care inhibitor and works by inhibiting the PIK3CA-AKT, a key cancer driver pathway. Fulvestrant is an anti-estrogen medication that blocks the estrogen receptor to prevent estrogen from stimulating breast cancer cell growth. Capivasertib and fulvestrant are approved by the U.S. Food and Drug Administration (FDA) for use in this type of cancer. Participants will be randomly assigned to receive either RLY-2608 in combination with fulvestrant, or capivasertib in combination with fulvestrant.
Eligibility
- * Patient has ECOG performance status of 0-1
- * One or more known primary oncogenic PIK3CA mutation(s)
- * Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 4 weeks prior to randomization and must be willing to continue on it for the duration of the study.
- * Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent
Where can I participate?
- CS Cancer Tarzana : Wendy Sabbah
- CS Cancer at Beverly Hills : Wendy Sabbah
- CS Cancer at Cedars-Sinai Medical Center : Wendy Sabbah
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
More about this Clinical Trial
What is the full name of this clinical trial?
RLY-2608-102: A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor