Ph3StudyGedatolisib Combw/Palbociclib&Fulvestrant toTherapiesw/HR+ HER2+AdvBeastCa PrevTreatw/CDK4/6

UCI Specialty Area: Cancer

Principal Investigator: Ritesh Parajuli

Official Title: A Phase III, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy

A Study On:

Breast

Study Description

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Eligibility

-Patients must be at least 18 years of age.

-Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment.

-Patients must have histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer.

Key

-Patients with prior treatment with chemotherapy and antibody drug conjugates (e.g., Enhertu) for advanced disease

-Patients with bone only disease that is only blastic with no soft tissue component

-Patients with type 1 diabetes or uncontrolled type 2 diabetes

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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