A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)

Study Overview
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Brief Summary
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This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.

Official Title
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A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Metastasectomy for the metastatic sites


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18-70 years old; ECOG score: 0-2 points; the expected life period is more than 3 months; Histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases; PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm; according to the RECIST 1.1 edition, there is at least one measurable lesion; the main organs are functioning normally, meeting the following criteria: Blood routine: Hb > 90g/L (no blood transfusion within 14 days); ANC > 1.5 x 109/L; PLT > 75 * 109/L;Liver function: total bilirubin TBIL is less than 1.5 x ULN (upper limit of normal value); ALT and AST are less than 3 x ULN; if there is liver metastasis, ALT and AST are less than 5 x ULN;Renal function: serum creatinine < 1 x ULN; participants voluntarily joined the study, signed informed consent, and followed up. Exclusion Criteria: the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection cannot be achieved; with metastatic lesions other than liver or lung patients with local recurrence palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc. pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives; involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study; severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgical group<br>The metastatic sites are firstly treated by surgery then followed by systemic treatment | Procedure: Metastasectomy for the metastatic sites<br>* patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy<br>|
| No Intervention: systemic group<br>After confirmation of puncture, receive systemic treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is calculated from randomization to death from any cause | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time To Event (TTE) | From date of randomization at baseline to the time of the first event (Disease progression, local recurrence or distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause), whichever came first, assessed up to 60 months | From date of randomization at baseline to the time of the first event, assessed up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastasectomy, oligo-metastatic breast cancer