A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
Eli Lilly and Company
Summary
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist. * If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agre…
Interventions
- DrugLY4064809
Administered orally
- DrugPlacebo
Administered orally
- DrugRibociclib
Administered orally
- DrugPalbociclib
Administered orally
- DrugAbemaciclib
Administered orally
- DrugAnastrozole
Administered orally
- DrugLetrozole
Administered orally
- Drug
Locations (317)
- Alaska Oncology and HematologyAnchorage, Alaska
- Ironwood Cancer & Research CentersChandler, Arizona
- Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- Genesis Cancer and Blood InstituteHot Springs, Arkansas
- Highlands Oncology GroupSpringdale, Arkansas