Clinical trial · Observational
Bone Metastasis and Surgery in Breast Cancer
The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only
- 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)
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery | Procedure | — | UNRESOLVED |
| Systemic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Systemic therapy
- description
- Standart chemotherapy
- interventionNames
- Drug: Systemic therapy
- label
- Primary surgery
- description
- Standart surgery
- interventionNames
- Procedure: Surgery
- label
- Neoadjuvant chemotherapy
- description
- Standart chemotherapy followed by surgery
- interventionNames
- Procedure: Surgery
- Drug: Systemic therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Primary breast tumor amenable for complete surgical resection * Patients in good physical condition for receiving protocol driven locoregional and systemic treatment * Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy. Exclusion Criteria: * Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d) * Primary tumor with extended infection, bleeding, or necrosis * Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment * Synchronous primary cancer at the contralateral breast * Previous diagnosis of other cancers (excluding basal cell skin cancer * Squamous cell skin cancer * Cervical intraepithelial neoplasia) * Clinically involved contralateral axillary nodes * Patients not suitable for adequate follow-up * Failure to give informed consent
References
Publications (0)
Data not yet available