Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

Surgery Clinical Trial

— SYSBTC-001  

Official title:

Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456855
• Other study ID #: SYSEC-KY-2018-018
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, PhD
• Phone: +8613500018020
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: July 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.

• ECOG-PS 0-2.

• Bone marrow, liver and kidney should be fully functional.

• Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo.

• For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.

Exclusion Criteria:

• Accompanied with other primary malignant tumors.

• Patients who can't plan for follow-up effectively and regularly.

• Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasm Female
• Breast Neoplasms
• Surgery

Intervention

Procedure:
• Locoregional surgery
Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.

Locations

Country	Name	City	State
China	First People's Hospital of Foshan	Foshan	Guangdong
China	Sun Yat-Sen Memorial Hospital of Sun Yat-sen	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	First People's Hospital of Foshan, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.	5 years
Secondary	Locoregional progression free survival	Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.	5 years
Secondary	Distant progression free survival	Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.	5 years