Clinical trial · Observational
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
NCT04456855CI-TRIAL-00045833SYSBTC-001unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.
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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Neoplasm Female | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Locoregional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Locoregional surgery
- interventionNames
- Procedure: Locoregional surgery
- label
- No surgery
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 years
- description
- The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
Secondary outcomes (2)
- measure
- Locoregional progression free survival
- timeFrame
- 5 years
- description
- Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination. * ECOG-PS 0-2. * Bone marrow, liver and kidney should be fully functional. * Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo. * For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed. Exclusion Criteria: * Accompanied with other primary malignant tumors. * Patients who can't plan for follow-up effectively and regularly. * Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.
References
Publications (1)
- DERIVEDYu Y, Hong H, Wang Y, Fu T, Chen Y, Zhao J, Chen P, Cai R, Tan Y, He Z, Ren W, Zhou L, Huang J, Tang J, Ye G, Yao H. Clinical Evidence for Locoregional Surgery of the Primary Tumor in Patients with De Novo Stage IV Breast Cancer. Ann Surg Oncol. 2021 Sep;28(9):5059-5070. doi: 10.1245/s10434-021-09650-3. Epub 2021 Feb 3. PMID 33534046