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

  • STATUS
    Recruiting
  • participants needed
    172
  • sponsor
    Fudan University
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Updated on 16 February 2024
See if I qualify
blood transfusion
measurable disease
metastasis
liver metastasis
kidney function tests
stage iv breast cancer
pet/ct scan

Summary

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

Details
Condition Breast Cancer, Breast Cancer
Age 18years - 70years
Treatment Metastasectomy for the metastatic sites
Clinical Study IdentifierNCT04413409
SponsorFudan University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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
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