Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University
About this trial
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
Eligibility criteria
Qualifiers
Patients need to meet all of the following conditions
Patients must be ≥18 and ≤ 75 years of age;
Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER >10%, or/and PR>10%, HER 0 OR +, if HER2++, FISH negative);
SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H&E sections;
Disqualifiers
Patients with any of the following conditions were excluded from the study
Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
Trial design
Treatments tested in this trial
- Apatinib
- CDK4/6 Inhibitor
- Aromatase inhibitor and Fulvestrant
Treatment groups
184 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov