A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metastasectomy for the metastatic sites
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastasectomy, oligo-metastatic breast cancer
Eligibility Criteria
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;
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
surgical group
systemic group
Arm Description
The metastatic sites are firstly treated by surgery then followed by systemic treatment
After confirmation of puncture, receive systemic treatment
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival is calculated from randomization to death from any cause
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04413409
Brief Title
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)
Official Title
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 10, 2023 (Anticipated)
Study Completion Date
March 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized clinical trial (OMIT study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastasectomy, oligo-metastatic breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgical group
Arm Type
Experimental
Arm Description
The metastatic sites are firstly treated by surgery then followed by systemic treatment
Arm Title
systemic group
Arm Type
No Intervention
Arm Description
After confirmation of puncture, receive systemic treatment
Intervention Type
Procedure
Intervention Name(s)
Metastasectomy for the metastatic sites
Intervention Description
patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival is calculated from randomization to death from any cause
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Time To Event (TTE)
Description
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
Time Frame
From date of randomization at baseline to the time of the first event, assessed up to 60 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZhiMin Shao, MD, PhD
Phone
+86-21-64175590
Ext
8808
Email
zhimingshao@yahoo.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhimin shao
Phone
+86-21-64175590
Ext
8808
Email
zhimingshao@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial Evaluating the Efficacy of Metastasectomy in Patients With Oligo-Metastatic Breast Cancer(OMIT)
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