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

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04456855
• Collaborator: Sun Yat-sen University (Other), First People's Hospital of Foshan (Other)
• Enrollment: 358
• Locations: 3
• Anticipated Duration (Months): 22.9
• Patients Per Site: 119.3
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Female; Surgery; Advanced Breast Cancer	Procedure: Locoregional surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 358 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
• Actual Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Oct 30, 2020
• Anticipated Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Overall survival [5 years]

   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.

Secondary Outcome Measures

1. Locoregional progression free survival [5 years]

   Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.

2. Distant progression free survival [5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First People's Hospital of Foshan	Foshan	Guangdong	China	528000
2	Sun Yat-Sen Memorial Hospital of Sun Yat-sen	Guangzhou	Guangdong	China	510120
3	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Sun Yat-sen University
• First People's Hospital of Foshan

Investigators

• Study Chair: Herui Yao, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Principal Investigator: Jun Tang, PhD, Sun Yat-sen University
• Principal Investigator: Guolin Ye, PhD, First People's Hospital of Foshan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Herui Yao, Principal Investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT04456855
• Other Study ID Numbers: SYSEC-KY-2018-018
• First Posted: Jul 7, 2020
• Last Update Posted: Jul 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Herui Yao, Principal Investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: Breast Neoplasm Female; Locoregional surgery; In de novo stage IV brest cancer; Overall survival; Locoregional progression free survival; Distant progression free survival
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jul 7, 2020