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

Summary

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.

Conditions

• Breast Cancer
• Stage IV Breast Cancer
• Bone Metastases

Interventions

PROCEDURE

Primary Tumor Resection

Surgical removal of the primary breast tumor. The procedure type (mastectomy or breast-conserving surgery) is determined by tumor size, location, and patient preference, and is performed by experienced breast surgeons following national guidelines. Axillary staging (sentinel node biopsy or dissection) is performed concurrently. Immediate breast reconstruction (prosthesis or autologous tissue) may be performed when indicated.

OTHER

Standard systemic therapy

Systemic treatment administered according to the patient's molecular subtype (HR+, HER2+, or Triple-negative) based on Chinese and international clinical guidelines. Regimens include, but are not limited to, endocrine therapy (e.g., letrozole, exemestane) with or without CDK4/6 inhibitors (e.g., palbociclib) for HR+/HER2- disease; anti-HER2 targeted therapy (e.g., trastuzumab, pertuzumab) combined with chemotherapy for HER2+ disease; and chemotherapy (e.g., taxanes, anthracyclines) with or without immunotherapy (e.g., pembrolizumab) for triple-negative disease. All patients with bone metastases routinely receive bone-modifying agents (zoledronic acid or denosumab).

Sponsors & Collaborators

• The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Nineth Hospital of Shenzhen, Longgang Center Hospital

  collaborator UNKNOWN

• Baotou Cancer Hospital

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Tangshan People's Hospital

  collaborator OTHER

• Guangdong Women and Children Hospital

  collaborator OTHER

• Nanchang People's Hospital

  collaborator UNKNOWN

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Xinjiang Medical University Cancer Hospital

  collaborator UNKNOWN

• Anyang Tumor Hospital

  collaborator OTHER

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Shanxi Province Cancer Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• West China Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2031-09-01

Completion

2036-12-31