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Brief Title: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
Official Title: Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting
Study ID: NCT05113966
Brief Summary: This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
Detailed Description: The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of the first dose of study treatment and completes at the Safety Follow-up Visit. Trilaciclib and sacituzumab govitecan-hziy will be administered intravenously (IV) in 21-day cycles. Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first. The first Survival Follow-up assessment should occur approximately 3 months after the Safety Follow-Up Visit and will continue every 3 months until the end of the study (or death).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ironwood Physicians, Chandler, Arizona, United States
Comprehensive Blood & Cancer Center, Bakersfield, California, United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States
Valkyrie Clinical Trials, Los Angeles, California, United States
UCLA Hematology/Oncology Parkside, Santa Monica, California, United States
PIH Health, Whittier, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Memorial Healthcare System, Hollywood, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Duly Health and Care, Joliet, Illinois, United States
New England Cancer Specialists, Scarborough, Maine, United States
Minnesota Oncology Hematology, P.A., Woodbury, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Northwest Cancer Specialists, PC, Tigard, Oregon, United States
Texas Oncology - Austin Central, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Longview Cancer Center, Longview, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc, Roanoke, Virginia, United States
Multicare Health System, Auburn, Washington, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
Name: Clinical Conduct
Affiliation: G1 Therapeutics, Inc.
Role: STUDY_DIRECTOR