Clinical trial · Interventional
Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Breast Cancer Patients
Compare the Efficacy of Surgery Combined With Systemic Therapy and Pure Systemic Therapy in Patients With Stage Ⅳ Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In clinical treatment, most patients with stage IV breast cancer received surgical treatment, which made it difficult to enroll this project, so this study was terminated.
Summary
Brief summary (as posted)
The purpose of this study is to compare the effect of primary resection combined with systemic therapy and pure systemic therapy on the overall survival of patients with stage Ⅳ breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surgery combined with systemic therapy | Combination Product | — | UNRESOLVED |
| systemic therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- surgery combined with systemic therapy
- description
- surgery combined with systemic therapy
- interventionNames
- Combination Product: surgery combined with systemic therapy
- type
- ACTIVE_COMPARATOR
- label
- systemic therapy
- description
- systemic therapy
- interventionNames
- Other: systemic therapy
Primary outcomes (1)
- measure
- OS
- timeFrame
- up to 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * • Sign the informed consent * ages 18-70, female; * Breast cancer meets the following criteria: * Histologically diagnosed invasive breast cancer, measure distant metastases with local standard assessment methods; * Known hormone receptors and HER-2 status (ER, PR and HER2); * Eastern Cooperative Oncology Group (ECOG) performance status score ≤1; * Estimated patient survival beyond 1 year; * The time from diagnosis or systemic treatment to randomization does not exceed 1 year; * According to RECIST 1.1, patients receiving chemotherapy or endocrine therapy are effective, including complete remission, partial remission, or stabilization. If the patient only receives endocrine therapy, the time is not less than 6 months; when receiving chemotherapy, the number of cycles is not less than 4 cycles; * HER2-positive patients: the proportion of patients receiving targeted therapy is not less than 80% of the total HER2-positive patients; * Patients had no obvious surgical contraindications before randomization; * Researchers judge that they can comply with the research protocol Exclusion Criteria: * • Double breast cancer; * Progression of metastases after systemic treatment; * Poorly controlled brain metastases, liver metastases and multiple metastases; * History of local breast radiotherapy after diagnosis; * Have a history of other malignancies within 5 years prior to screening, with cervical cancer in situ treated properly except for non-melanoma skin cancer or stage I uterine cancer; * Have undergone a major breast cancer-free surgical procedure within 4 weeks before randomization, or the patient has not fully recovered from such a surgical procedure; * Have severe comorbidities or other comorbid conditions that interfere with planned treatment, or any other condition in which the investigator does not consider the patient suitable for participation in the study. * Patients can withdraw informed consent at any time; * pregnancy; * The sponsor has determined that a major protocol violation that could compromise patient safety; * Patients' non-compliance with protocol requirements on multiple occasions; * The investigator believes that withdrawal from the trial will be of greatest benefit to the patient.
References
Publications (0)
Data not yet available