Last updated 2 days ago
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
1056 patients around the world
Available in Brazil, Puerto Rico, United States
BeOne Medicines
3Research sites
1056Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.Adequate organ function.
- Participants who have received prior systemic treatment in the advanced or metastatic setting.Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII (Hospital de AMOR)
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
BRCR Global
Recruiting
StudyKANDELA-302
SponsorBeOne Medicines
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07492641
