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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Metastasectomy for the metastatic sites

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ZhiMin Shao, MD, PhD; Phone Number: 8808 +86-21-64175590; Email: zhimingshao@yahoo.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: zhimin shao; Phone Number: 8808 +86-21-64175590; Email: zhimingshao@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgical group; The metastatic sites are firstly treated by surgery then followed by systemic treatment	Procedure: Metastasectomy for the metastatic sites; patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy
No Intervention: systemic group; After confirmation of puncture, receive systemic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival is calculated from randomization to death from any cause	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): March 10, 2023
• Study Completion (Anticipated): March 10, 2025

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: metastasectomy; oligo-metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FUSCC-OMIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No