Brief 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.

Conditions

• Breast Neoplasms
• Neoplasm Metastasis

Intervention / Treatment

• Drug: LY4064809
• Drug: Placebo
• Drug: Ribociclib
• Drug: Ribociclib
• Drug: Palbociclib
• Drug: Palbociclib
• Drug: Abemaciclib
• Drug: Abemaciclib
• Drug: Anastrozole
• Drug: Anastrozole
• Drug: Letrozole
• Drug: Letrozole
• Drug: Exemestane
• Drug: Exemestane
• Drug: Fulvestrant
• Drug: Fulvestrant

Primary Outcome Measures

• (Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) (Baseline through disease progression or death (Estimated up to 5 years))
  As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
• (Part 2): Progression-Free Survival (Baseline to objective progression or death due to any cause (Estimated up to 5 years))
  Investigator-assessed

Countries

Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Ireland, Italy, Japan, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

• Alaska Oncology and Hematology, Anchorage, United States (Not yet recruiting)
  • Steven Liu (Principal Investigator)
• Ironwood Cancer & Research Centers, Chandler, United States (Recruiting)
  • Jasleen Khanuja (Principal Investigator)
• St. Joseph's Hospital and Medical Center, Phoenix, United States (Not yet recruiting)
  • Albert Wendt (Principal Investigator)
• Mayo Clinic in Arizona - Phoenix, Phoenix, United States (Not yet recruiting)
  • Shakeela Bahadur (Principal Investigator)
• The University of Arizona Cancer Center - North Campus, Tucson, United States (Recruiting)
  • Sima Ehsani (Principal Investigator)
• Genesis Cancer and Blood Institute, Hot Springs, United States (Not yet recruiting)
  • Stephen Divers (Principal Investigator)
• Highlands Oncology Group, Springdale, United States (Recruiting)
  • Joseph Beck (Principal Investigator)
• Community Cancer Institute, Clovis, United States (Not yet recruiting)
  • Li Ge (Principal Investigator)
• City of Hope, Duarte, United States (Recruiting)
  • Hope Rugo (Principal Investigator)
• Epic Care - Emeryville, Emeryville, United States (Recruiting)
  • srikanth reddy (Principal Investigator)
• Marin Cancer Care, Greenbrae, United States (Recruiting)
  • Cyrus Mazidi (Principal Investigator)
• Chao Family Comprehensive Cancer Center and Ambulatory Care (CIACC) - Irvine, Irvine, United States (Not yet recruiting)
  • Ritesh Parajuli (Principal Investigator)
• City of Hope Orange County Lennar Foundation Cancer Center, Irvine, United States (Recruiting)
  • Hope Rugo (Principal Investigator)
• Moores Cancer Center, La Jolla, United States (Not yet recruiting)
  • Xiaojie Zhang (Principal Investigator)
• USC/Norris Comprehensive Cancer Center, Los Angeles, United States (Not yet recruiting)
  • Daphne Stewart (Principal Investigator)
• Hoag Memorial Hospital Presbyterian, Newport Beach, United States (Not yet recruiting)
  • Chaitali Nangia (Principal Investigator)
• Kaiser Permanente Oakland, Oakland, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• Profound Research LLC, Oceanside, United States (Recruiting)
  • Catherine Quinn (Principal Investigator)
• University of California, Irvine (UCI) Health - UC Irvine Medical Center, Orange, United States (Not yet recruiting)
  • Ritesh Parajuli (Principal Investigator)
• Desert Regional Medical Center, Palm Springs, United States (Not yet recruiting)
  • Kim Phan (Principal Investigator)
• Stanford Cancer Center, Palo Alto, United States (Not yet recruiting)
  • Fauzia Riaz (Principal Investigator)
• Kaiser Permanente, Roseville, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• Kaiser Permanente, San Francisco, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• Kaiser Permanente, Santa Clara, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• UCLA Hematology/Oncology - Parkside, Santa Monica, United States (Not yet recruiting)
  • Nicholas McAndrew (Principal Investigator)
• Providence Medical Foundation, Santa Rosa, United States (Recruiting)
  • Ian Anderson (Principal Investigator)
• Kaiser Permanente, Vallejo, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• Kaiser Permanente Walnut Creek, Walnut Creek, United States (Not yet recruiting)
  • Jennifer Suga (Principal Investigator)
• UCHealth Harmony, Fort Collins, United States (Not yet recruiting)
  • Chelsea Gawryletz (Principal Investigator)
• Cancer Centers of Colorado St. Mary's Regional Hospital, Grand Junction, United States (Not yet recruiting)
  • Alicia Swink (Principal Investigator)
• Banner MD Anderson Cancer Center at North Colorado Medical Center, Greeley, United States (Not yet recruiting)
  • Esther Mondo (Principal Investigator)
• Banner MD Anderson Cancer Center at McKee Medical Center, Loveland, United States (Not yet recruiting)
  • Esther Mondo (Principal Investigator)
• UConn Health, Farmington, United States (Not yet recruiting)
  • Yueming Chang (Principal Investigator)
• MedStar Washington Hospital Center, Washington D.C., United States (Recruiting)
  • Ami Chitalia (Principal Investigator)
• AdventHealth Altamonte Springs, Altamonte Springs, United States (Not yet recruiting)
  • Wassim Mchayleh (Principal Investigator)
• Clermont Oncology Center, Clermont, United States (Recruiting)
  • Gopal Kunta (Principal Investigator)
• Florida Oncology & Hematology, Fort Myers, United States (Recruiting)
  • Venkata Parsa (Principal Investigator)
• Mayo Clinic in Florida, Jacksonville, United States (Not yet recruiting)
  • Rishitha Bollam (Principal Investigator)
• University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, United States (Not yet recruiting)
  • Frances Valdes (Principal Investigator)
• Mid Florida Hematology and Oncology Center, Orange City, United States (Recruiting)
  • Santosh Nair (Principal Investigator)
• Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center, Tampa, United States (Not yet recruiting)
  • Aixa Soyano (Principal Investigator)
• Piedmont Columbus Regional - John B. Amos Cancer Center, Columbus, United States (Not yet recruiting)
  • Andrew Pippas (Principal Investigator)
• Central Georgia Cancer Care, Macon, United States (Recruiting)
  • Bradley Sumrall (Principal Investigator)
• City of Hope National Medical Center, Atlanta Cancer Center, Newnan, United States (Recruiting)
  • Sarah Friend (Principal Investigator)
• Low Country Cancer Care, Savannah, United States (Not yet recruiting)
  • Jennifer Yannucci (Principal Investigator)
• Summit Cancer Care, PC, Savannah, United States (Recruiting)
  • Alison Spellman (Principal Investigator)
• Kaiser Permanente Moanalua Medical Center, Honolulu, United States (Not yet recruiting)
  • Jennifer Carney (Principal Investigator)
• City of Hope, Chicago, Chicago, United States (Recruiting)
  • Teja Poosarla (Principal Investigator)
• Northwestern Memorial Hospital, Chicago, United States (Not yet recruiting)
  • William Gradishar (Principal Investigator)
• University of Illinois at Chicago, Chicago, United States (Not yet recruiting)
  • Oana Danciu (Principal Investigator)

And 313 other sites.

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (Study Director) — Eli Lilly and Company