Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Primary Tumor Resection | Procedure | — | UNRESOLVED |
| Standard systemic therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery Group
- description
- Patients undergo primary tumor surgery (total mastectomy or breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection, with or without immediate breast reconstruction) within 4 weeks after randomization, followed by continued standard systemic therapy.
- interventionNames
- Procedure: Primary Tumor Resection
- type
- ACTIVE_COMPARATOR
- label
- Non-Surgery Group
- description
- Patients receive standard systemic therapy alone based on their molecular subtype (e.g., HR+/HER2-: endocrine therapy ± CDK4/6 inhibitor; HER2+: anti-HER2 therapy + chemotherapy; Triple-negative: chemotherapy ± immunotherapy). Palliative local therapy (e.g., radiotherapy) for bone metastases or for managing severe local complications from the primary tumor (e.g., uncontrolled ulceration, bleeding) is permitted but not elective curative-intent primary tumor surgery.
- interventionNames
- Other: Standard systemic therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available