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

NCT ID: NCT04413409

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2025-03-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgical group

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

Group Type: EXPERIMENTAL

Metastasectomy for the metastatic sites

Intervention Type: PROCEDURE

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

systemic group

After confirmation of puncture, receive systemic treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metastasectomy for the metastatic sites

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

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

ZhiMin Shao, MD, PhD

Role: CONTACT

zhimingshao@yahoo.com

+86-21-64175590 ext. 8808

Facility Contacts

zhimin shao

Role: primary

zhimingshao@yahoo.com

+86-21-64175590 ext. 8808

Other Identifiers

FUSCC-OMIT

Identifier Type: -

Identifier Source: org_study_id