Clinical trial NCT04456855: Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Official title: Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm Female
Surgery
Advanced Breast Cancer
Keywords: Breast Neoplasm Female
Locoregional surgery
In de novo stage IV brest cancer
Overall survival
Locoregional progression free survival
Distant progression free survival
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: First People's Hospital of Foshan
First posted: 2020-07-07
Enrollment: 358
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Locoregional progression free survival
timeFrame: 5 years
measure: Distant progression free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-sen
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Herui Yao, PhD
role: STUDY_CHAIR
affiliation: Sun Yat-sen University
name: Jun Tang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Foshan
name: Guolin Ye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.