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

STATUS

Recruiting
days left to enroll

79
participants needed

172
sponsor

Fudan University

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Updated on 19 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 Identifier	NCT04413409
Sponsor	Fudan University
Last Modified on	19 February 2024

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