Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases

This is a national multicenter, prospective, randomized controlled trial. The study aims to compare the 5-year overall survival (OS) between patients receiving primary tumor surgery followed by systemic therapy (surgery group) and those receiving systemic therapy alone (non-surgery group) in patients with de novo Stage IV breast cancer who have solitary bone metastases. Secondary objectives include comparing progression-free survival (PFS), breast cancer-specific survival (BCSS), local control rates, patient-reported outcomes (BREAST-Q, QLQ-C30), safety (surgical complications and systemic therapy toxicities), and cost-effectiveness.

NCT Number	NCT07687225
Lead Sponsor	West China Hospital Collaborators: The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, The Nineth Hospital of Shenzhen, Longgang Center Hospital, Baotou Cancer Hospital, Hebei General Hospital, General Hospital of Ningxia Medical University, The First Hospital of Jilin University, Tangshan People's Hospital, Guangdong Women and Children Hospital, Nanchang People's Hospital, Cancer Hospital of Guangxi Medical University, Xinjiang Medical University Cancer Hospital, Anyang Tumor Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shanxi Bethune Hospital, Hebei Medical University Fourth Hospital, The Affiliated Hospital of Qingdao University, Suzhou Municipal Hospital, Zhejiang Provincial People's Hospital, Hunan Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanxi Province Cancer Hospital, LanZhou University, Lanzhou University Second Hospital
Conditions	Breast Cancer, Stage IV Breast Cancer, Bone Metastases
Enrollment	216 participants
Start Date	2026-09-01
Primary Completion	2031-09-01 (estimated)
Study Completion	2036-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-07