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

NCT ID: NCT04456855

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasm Female Surgery Advanced Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Locoregional surgery

Locoregional surgery

Intervention Type PROCEDURE

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

No surgery

No interventions assigned to this group

Interventions

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Locoregional surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Herui Yao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herui Yao, PhD

Role: STUDY_CHAIR

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

Jun Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Guolin Ye, PhD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Foshan

Locations

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First People's Hospital of Foshan

Foshan, Guangdong, China

Site Status RECRUITING

Sun Yat-Sen Memorial Hospital of Sun Yat-sen

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Herui Yao, PhD

Role: CONTACT

+8613500018020

Yunfang Yu, MD

Role: CONTACT

+8613660238987

Facility Contacts

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Guolin Ye, PhD

Role: primary

Herui Yao, PhD

Role: primary

+8613500018020

Jun Tang, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33534046 (View on PubMed)

Other Identifiers

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SYSEC-KY-2018-018

Identifier Type: -

Identifier Source: org_study_id

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