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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Metastasectomy for the metastatic sites

• Registration Number: NCT04413409
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-03-07
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2023-03-10
• Study Completion: 2025-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 172

Inclusion Criteria

1. women aged 18-70 years old;
2. ECOG score: 0-2 points;
3. the expected life period is more than 3 months;
4. Histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases;
5. PET-CT or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm;
6. according to the RECIST 1.1 edition, there is at least one measurable lesion;
7. 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;
8. participants voluntarily joined the study, signed informed consent, and followed up.

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Exclusion Criteria

1. the number of metastastatic sites ≥ 3, or the surgeon determines that the R0 resection cannot be achieved;
2. with metastatic lesions other than liver or lung
3. patients with local recurrence
4. palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions
5. has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc.
6. pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives;
7. involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study;
8. severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgical group	Metastasectomy for the metastatic sites	The metastatic sites are firstly treated by surgery then followed by systemic treatment

Primary Outcome Measures

Name	Time	Method
Overall Survival	3-year	Overall survival is calculated from randomization to death from any cause

Secondary Outcome Measures

Name	Time	Method
Time To Event (TTE)	From date of randomization at baseline to the time of the first event, assessed up to 60 months	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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China