Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients (SYSBTC-001)

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.

Study Overview

• Status: Unknown
• Conditions: Advanced Breast Cancer; Surgery; Breast Neoplasm Female
• Intervention / Treatment: Procedure: Locoregional surgery

• Study Type: Observational
• Enrollment (Anticipated): 358

Contacts and Locations

• Study Contact: Name: Herui Yao, PhD; Phone Number: +8613500018020; Email: yaoherui@mail.sysu.edu.cn
• Study Contact Backup: Name: Yunfang Yu, MD; Phone Number: +8613660238987; Email: yuyf9@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Recruiting
      • First People's Hospital of Foshan
      • Contact: Guolin Ye, PhD; Email: 13902816950@139.com
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-sen
      • Contact: Herui Yao, PhD; Phone Number: +8613500018020; Email: yaoherui@mail.sysu.edu.cn
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Jun Tang, PhD; Email: tangjun@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Locoregional surgery	Procedure: Locoregional surgery; Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.
No surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional progression free survival	Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.	5 years
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Sun Yat-sen University; First People's Hospital of Foshan
• Investigators: Principal Investigator: Jun Tang, PhD, Sun Yat-sen University; Principal Investigator: Guolin Ye, PhD, First People's Hospital of Foshan

Publications and helpful links

General Publications

• Yu Y, Hong H, Wang Y, Fu T, Chen Y, Zhao J, Chen P, Cai R, Tan Y, He Z, Ren W, Zhou L, Huang J, Tang J, Ye G, Yao H. Clinical Evidence for Locoregional Surgery of the Primary Tumor in Patients with De Novo Stage IV Breast Cancer. Ann Surg Oncol. 2021 Sep;28(9):5059-5070. doi: 10.1245/s10434-021-09650-3. Epub 2021 Feb 3.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Overall survival; Breast Neoplasm Female; Locoregional surgery; In de novo stage IV brest cancer; Locoregional progression free survival; Distant progression free survival
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSEC-KY-2018-018

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