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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413409
• Other study ID #: FUSCC-OMIT
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: March 10, 2025

Study information

• Verified date: June 2020
• Source: Fudan University
• Contact: ZhiMin Shao, MD, PhD
• Phone: +86-21-64175590
• Email: zhimingshao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: March 10, 2025
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Metastasectomy for the metastatic sites
patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival is calculated from randomization to death from any cause	3-year
Secondary	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	From date of randomization at baseline to the time of the first event, assessed up to 60 months