Active, not yet recruiting
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)
NCT No.: NCT07174336
Study Type: INTERVENTIONAL
Phase:
Phase III
Official Title
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)
Purpose
The purpose of this research study is to learn more about LY4064809, a possible new medicine for the treatment of advanced breast cancer. There are 2 parts to the study, Part 1 and Part 2. The purpose of Part1 is to find an optimal dose for Part 2. This ICF is for Part 2 and your doctor has determined that you are now eligible to participate in Part 2 of the study. Part 2 of the study compares the study results across the 2 treatment arms (Arms A and B). Participants will receive either LY4064809 or placebo combined with an Endocrine Therapy which includes an aromatase inhibitor (letrozole, anastrozole, or exemestane) or fulvestrant and 1 of the 3 cyclin-dependent kinase (CDK)4/6 inhibitors (ribociclib, palbociclib, or abemaciclib).
Detailed Description
This study will evaluate the combination of LY4064809 with ET and a CDK4/6 inhibitor, with an initial focus on safety and efficacy in patients receiving initial therapy for HR+, HER2-, PIK3CA-mutated advanced breast cancer (aBC).
Eligibility Criteria
Inclusion Criteria
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1) 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.
2) 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.
3) If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.
4) Have histologically or cytologically confirmed breast cancer, defined as individuals with
a) locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and
b) hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of
American Pathologists (CAP) Guidelines.
-HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally.
-HER status: immunohistochemistry score of 1+ or score of 2+ with a negative
Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines.
5) Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.
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Exclusion Criteria
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1) Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter [mmol/L]), or requiring insulin.
2) Have inflammatory or metaplastic breast cancer.
3) History of leptomeningeal disease or carcinomatous meningitis.
4) Have known and untreated or active central nervous system (CNS) metastases. Exception:
Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of adiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.
5) Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.
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Keywords and/or Specific Medical Conditions
Sponsors
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