Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age65+
SponsorFudan University
About this trial
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.
Eligibility criteria
Qualifiers
≥4 positive lymph nodes
Disqualifiers
1. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).
Trial design
Treatments tested in this trial
- Chemotherapy
- CDK4/6 Inhibitor
- Endocrine therapy
Treatment groups
1,244 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov