Breast Neoplasm FemaleSYSBTC-001NCT04456855
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
An observational study of Breast Neoplasm Female and Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Surgery, Advanced Breast Cancer
- What is being tested?
- Locoregional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 358 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2019to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
First People's Hospital of Foshan
Foshan, Guangdong, 528000
Guolin Ye, PhD, 13902816950@139.com
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-sen
Guangzhou, Guangdong, 510120
Herui Yao, PhD, +8613500018020, yaoherui@mail.sysu.edu.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510120
Jun Tang, PhD, tangjun@sysucc.org.cn
About this study
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.
- Conditions
- Breast Neoplasm Female, Surgery, Advanced Breast Cancer
- Being tested
- Locoregional surgery
- Keywords
- Breast Neoplasm Female, Locoregional surgery, In de novo stage IV brest cancer, Overall survival, Locoregional progression free survival, Distant progression free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locoregional surgeryProcedure or surgery
Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Locoregional surgery | Not described Receives: Procedure: Locoregional surgery | |
| No surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Locoregional progression free survival
Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Sep 2019
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Herui Yao, PhD, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityJun Tang, PhD, Principal investigator, Sun Yat-sen UniversityGuolin Ye, PhD, Principal investigator, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456855
- Sponsor's protocol ID
- SYSEC-KY-2018-018
- Acronym
- SYSBTC-001
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04456855
- Acronym / sponsor ID
- SYSBTC-001 / SYSEC-KY-2018-018
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, First People's Hospital of Foshan
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locoregional surgery | – | Procedure: Locoregional surgery |
| No surgery | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locoregional surgeryPatients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer. | Procedure or surgery | Locoregional surgery |
Primary outcome
Overall survival
Time frame: 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.
2 secondary outcomes
Locoregional progression free survival
Time frame: 5 years
Distant progression free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 33534046Yu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female and Surgery, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herui Yao, PhD (+8613500018020, yaoherui@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04456855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.