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NCT07687225Not yet recruiting

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

A National Multicenter, Prospective, Randomized Controlled Trial Comparing Primary Tumor Surgery Followed by Systemic Therapy With Systemic Therapy Alone in Patients With De Novo Stage IV Breast Cancer and Solitary Bone Metastases

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
216 (estimated)
First submitted
24 Jun 2026
Start date
1 Sept 2026
Primary completion date
1 Sept 2031
Lead sponsor
West China Hospital
NCT number
NCT07687225

What you commit to

  • Study type: Interventional
  • Planned participants: 216
  • From 1 Sept 2026 to the primary completion date, 1 Sept 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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);

Other

  • Current participation in another clinical trial that would interfere with the outcomes of this study;
  • Refusal to provide informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.