Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04456855
Acronym
SYSBTC-001
Enrollment
358
Registered
2020-07-07
Start date
2019-09-01
Completion date
2021-07-30
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer, Breast Neoplasm Female, Surgery

Keywords

Breast Neoplasm Female, Locoregional surgery, In de novo stage IV brest cancer, Overall survival, Locoregional progression free survival, Distant progression free survival

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.

Interventions

PROCEDURELocoregional surgery

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

Sponsors

Sun Yat-sen University
CollaboratorOTHER
First People's Hospital of Foshan
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival5 yearsThe 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

MeasureTime frameDescription
Locoregional progression free survival5 yearsDefined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
Distant progression free survival5 yearsDistant 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.

Countries

China

Contacts

Primary ContactHerui Yao, PhD
yaoherui@mail.sysu.edu.cn+8613500018020
Backup ContactYunfang Yu, MD
yuyf9@mail.sysu.edu.cn+8613660238987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026