Status:
UNKNOWN
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2025
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04413409
Start Date
December 10 2019
End Date
March 10 2025
Last Update
June 4 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032