Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases
Starting soon · Not applicable
Conditions studied: Breast Cancer, Stage IV Breast Cancer, Bone Metastases
In brief
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.
Key facts
- Study ID
- NCT07687225
- Run by
- West China Hospital
- People needed
- 216
- Starts
- 2026-09-01
- Expected to finish
- 2036-12-31
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female patients aged 18 to 70 years (inclusive);
- Histopathologically confirmed (by core needle biopsy) invasive breast cancer;
- Diagnosed with de novo Stage IV breast cancer with metastases confirmed to be limited to bone;
- Patients may be enrolled either at initial diagnosis or after receiving first-line systemic therapy;
- Willing and able to provide written informed consent.
You may not qualify if…
- Disease progression (per RECIST 1.1 criteria) in the primary tumor, regional lymph nodes, or bone metastases after first-line systemic therapy;
- Presence of other primary malignancies;
- Severe comorbidities that would preclude surgery or safe administration of systemic therapy (e.g., severe cardiopulmonary disease, uncontrolled diabetes, long-term smoking history with poor pulmonary function, immunodeficiency);
- Current participation in another clinical trial that would interfere with the outcomes of this study;
- Refusal to provide informed consent.
Full record on ClinicalTrials.gov
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