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

NCT04413409 | Unknown DMC

• 1 other identifier: FUSCC-OMIT
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

metastasectomy; oligo-metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is calculated from randomization to death from any cause

  3-year

Secondary Outcomes (1)

• Time To Event (TTE)

  From date of randomization at baseline to the time of the first event, assessed up to 60 months

Study Arms (2)

surgical group

EXPERIMENTAL

The metastatic sites are firstly treated by surgery then followed by systemic treatment

Procedure: Metastasectomy for the metastatic sites

systemic group

NO INTERVENTION

After confirmation of puncture, receive systemic treatment

Interventions

Metastasectomy for the metastatic sites PROCEDURE

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

surgical group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Metastasectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

ZhiMin Shao, MD, PhD

CONTACT

+86-21-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: June 4, 2020
• Study Start: December 10, 2019
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2025
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)