CClinicalTrials.gg
Sign In
Status unknownNCT04456855SYSBTC-001Updated Jul 7, 2020

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

An observational study in Breast Neoplasm Female, Surgery and Advanced Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 3 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
358
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Neoplasm Female
  • Surgery
  • Advanced Breast Cancer

Browse trials for

Keywords

  • Breast Neoplasm Female
  • Locoregional surgery
  • In de novo stage IV brest cancer
  • Overall survival
  • Locoregional progression free survival
  • Distant progression free survival
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 358 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
358 participants (estimated)
Patient registry
No

Groups and cohorts

  • Locoregional surgery

    Procedure: Locoregional surgery

  • No surgery

Interventions

  • ProcedureLocoregional surgery

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. Locoregional progression free survival

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

    Time frame: 5 years

  2. 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.

    Time frame: 5 years

07

Study locations

3 of 3 sites recruiting
  • First People's Hospital of Foshan
    Foshan, Guangdong 528000, China
    Recruiting
  • Sun Yat-Sen Memorial Hospital of Sun Yat-sen
    Guangzhou, Guangdong 510120, China
    Recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510120, China
    Recruiting
08

References and documents

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. PubMed 33534046 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04456855
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Sun Yat-sen University, First People's Hospital of Foshan
Responsible party
Herui Yao (Principal Investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jul 7, 2020
Start date
Sep 1, 2019
Primary completion
Oct 30, 2020 (estimated)
Completion
Jul 30, 2021 (estimated)
Last update
Jul 7, 2020

Study contacts

Herui Yao, PhD
Contact
yaoherui@mail.sysu.edu.cn
+8613500018020
Yunfang Yu, MD
Contact
yuyf9@mail.sysu.edu.cn
+8613660238987
Herui Yao, PhD
study chair · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Jun Tang, PhD
principal investigator · Sun Yat-sen University
Guolin Ye, PhD
principal investigator · First People's Hospital of Foshan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Start the discussion