Last updated 16 days ago
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
800 patients around the world
Available in Argentina, United States, Belgium, Spain, Brazil
Eli Lilly and Company
12Research sites
800Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 agree to use hormone suppression with a GnRH agonist.Have histologically or cytologically confirmed breast cancer, defined as individuals withlocally advanced breast cancer not amenable to curative therapy or metastatic disease.Have 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.Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.Have measurable disease or non-measurable, evaluable bone disease.Part 1: Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy or metastatic disease.Up to 1 of these prior systemic treatments may contain chemotherapy.Part 2: Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy or metastatic disease.Individuals who are eligible are eitherPopulation 1 (P1): Endocrine sensitiveNewly diagnosed with advanced breast cancer (de novo).Relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor.Relapsed with documented evidence of progression greater than (>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.Population 2 (P2): Endocrine resistant.If a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be >12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.
- 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), or requiring insulin.Have inflammatory or metaplastic breast cancer.History of leptomeningeal disease or carcinomatous meningitis.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 radiographic 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.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.Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto de Investigaciones Clínicas Córdoba
Hospital Provincial del Centenario - Rosario, Santa Fe
Organización Médica de Investigación (OMI)
Recruiting
Instituto San Marcos Investigación - San Juan
Centro Oncológico Korben
Recruiting
Go Centro Médico San Nicolás
Diagnóstico Médico - Centro de Investigaciones Médicas y Desarrollo LC S.R.L. - CABA
Centro Médico Focus - CECIC
Fundación Respirar
StudyPIKALO-2
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07174336
