Advanced Breast CancerNCT03047889
A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast
An observational study of Advanced Breast Cancer, run by Chinese Academy of Medical Sciences at 19 sites in China.
Trial summary
To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- standard therapy
- How many people
- 4,200 participants
- Where
- 19 sitesChina
- Study dates
- Apr 2016to Dec 2017
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 21 hospitals were selected in this study. The investigators recruited 4200 advanced BC cases, who were first diagnosed with advanced BC from January 1st, 2012 to December 31st, 2014 from these hospitals.
Who may be able to join
- diagnosed as advanced breast cancer during Jan1st,2012-Dec31st,2014
- complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.In any age, ethnic group cases.
Who cannot join
- no available medical record
Trial locations and contacts
19 sites in 1 country.
Binghe Xu contact
19 sites in 1 country
China19 sites, 19 recruiting
- Not yet recruiting
The 307th Hospital of Military Medical Sciences
Beijing
Zefei Jiang
- Not yet recruiting
Sichuan Cancer Hospital and Institute
Chengdu
Hui Li
- Not yet recruiting
The First Affliated Hospital of Chongqing Medical University
Chongqing
Hongyuan Li
- Not yet recruiting
FuZhou General Hospital of National Miltary Command
Fuzhou
Xuenong Ouyang
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
Shuseng Wang
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin
Li Cai
- Not yet recruiting
Henan Cancer Hospital
Henan
Min Yan
- Not yet recruiting
Hunan Cancer Hospital
Hunan
Quchang Ouyang
- Not yet recruiting
Jiangsu Provinces hospital
Jiangsu
Yongmei Yin
- Not yet recruiting
Tumor Hospital of Yunnan Province
Kunming
Runxiang Yang
- Not yet recruiting
Liaoning Cancer Hospital, Zhejiang Cancer Hospital
Liaoning
Tao Sun
- Recruiting
General Hospital of NingXia Medical University
Ningxia
Xinlan Liu
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai
Xichun Hu
- Not yet recruiting
The First Hospital of China Medical University
Shenyang
Yuee Teng
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Zhongsheng Tong
- Not yet recruiting
Wuhan Union Hospital
Wuhan
Tao Huang
- Not yet recruiting
The First Hospital of Xi'an Jiaotong University
Xi'an
Jianjun He
- Not yet recruiting
Xinjiang Medical University Cancer Hospital
Xinjiang
Shune Yang
- Not yet recruiting
FuJian Provincial Cancer Hospital
Zhengzhou
Jian Liu
About this study
To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results
Read the detailed description
In this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time.
To study the epidemiological trends and characteristics for advanced BC patients, to analyze these trends and report the results. To learn about the current treatment therapy for advanced BC patients in different areas in China.To provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced BC patients.To assess the different treatment therapies for advanced BC with consideration of economic cost-effectiveness
- Conditions
- Advanced Breast Cancer
- Being tested
- standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard therapyDrug
standard therapy for advanced/metastatic breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival status at 3 years
percentage of patients still alive at 3 years
Measured: 3 years
Secondary outcomes (2)
PFS
Progression-free survival of first line therapy
Measured: 3 years
Survival status at 5 years
percentage of patients still alive at 5 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, Principal investigator, Chinese Academy of Medical SciencesYoulin Qiao, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047889
- Sponsor's protocol ID
- CH-BC-045
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Han YQ, Yi ZB, Yu P, Wang WN, Ouyang QC, Yan M, Wang XJ, Hu XC, Jiang ZF, Huang T, Tong ZS, Wang SS, Yin YM, Li H, Yang RX, Yang HW, Teng YE, Sun T, Cai L, Li HY, Ouyang XN, He JJ, Liu XL, Yang SE, Qiao YL, Fan JH, Wang JY, Xu BH. Comparisons of Treatment for HER2-Positive Breast Cancer between Chinese and International Practice: A Nationwide Multicenter Epidemiological Study from China. J Oncol. 2021 Sep 15;2021:6621722. doi: 10.1155/2021/6621722. eCollection 2021.
PubMed 34567118Guo F, Yi Z, Wang W, Han Y, Yu P, Zhang S, Ouyang Q, Yan M, Wang X, Hu X, Jiang Z, Huang T, Tong Z, Wang S, Yin Y, Li H, Yang R, Yang H, Teng Y, Sun T, Cai L, Li H, Chen X, He J, Liu X, Yang S, Fan J, Qiao Y, Wang J, Xu B. Profile, treatment patterns, and influencing factors of anthracycline use in breast cancer patients in China: A nation-wide multicenter study. Cancer Med. 2021 Oct;10(19):6744-6761. doi: 10.1002/cam4.4215. Epub 2021 Sep 2.
PubMed 34472719Wu Y, Han Y, Yu P, Ouyang Q, Yan M, Wang X, Hu X, Jiang Z, Huang T, Tong Z, Wang S, Yin Y, Li H, Yang R, Yang H, Teng Y, Sun T, Cai L, Li H, Chen X, He J, Liu X, Yang S, Qiao Y, Fan J, Wang J, Xu B. Endocrine Therapy for Hormone Receptor-Positive Advanced Breast Cancer: A Nation-Wide Multicenter Epidemiological Study in China. Front Oncol. 2021 Feb 11;10:599604. doi: 10.3389/fonc.2020.599604. eCollection 2020.
PubMed 33643905Yi ZB, Yu P, Zhang S, Wang WN, Han YQ, Ouyang QC, Yan M, Wang XJ, Hu XC, Jiang ZF, Huang T, Tong ZS, Wang SS, Yin YM, Li H, Yang RX, Yang HW, Teng YE, Sun T, Cai L, Li HY, Chen X, He JJ, Liu XL, Yang SE, Wang JY, Fan JH, Qiao YL, Xu BH. Profile and outcome of receptor conversion in breast cancer metastases: a nation-wide multicenter epidemiological study. Int J Cancer. 2021 Feb 1;148(3):692-701. doi: 10.1002/ijc.33227. Epub 2020 Aug 19.
PubMed 32700765
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nation-wide Multicenter Clinical Epidemiologic Study of Chinese Females With Advanced Breast
- ClinicalTrials.gov ID
- NCT03047889
- Acronym / sponsor ID
- CH-BC-045
- Conditions
- Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
To study the epidemiological trends and characteristics for advanced breast cancer patients, to analyze these trends and report the results
Detailed description
In this study, the investigators conducted a hospital-based retrospective clinical study, recruiting female advanced breast cancer patients from 14 tertiary hospitals at 7 classic geographic regions, to study the clinical epidemiologic characteristics of advanced breast cancer and the current standard of clinical diagnosis and treatment in order to provide references for standardized treatment therapy, and to improve the quality of life and prolong survival time.
To study the epidemiological trends and characteristics for advanced BC patients, to analyze these trends and report the results. To learn about the current treatment therapy for advanced BC patients in different areas in China.To provide references for standardized treatment therapy, to improve the quality of patients' life and to prolong the survival time for the advanced BC patients.To assess the different treatment therapies for advanced BC with consideration of economic cost-effectiveness
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 21 hospitals were selected in this study. The investigators recruited 4200 advanced BC cases, who were first diagnosed with advanced BC from January 1st, 2012 to December 31st, 2014 from these hospitals.
Key inclusion criteria (2 listed)
- diagnosed as advanced breast cancer during Jan1st,2012-Dec31st,2014
- complete with surgical pathology data, auxiliary treatment, there is a clear recurrence, transfer time, place, transfer of recurrence after treatment, and curative effect evaluation details.In any age, ethnic group cases.
Key exclusion criteria (1 listed)
- no available medical record
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 |
|---|---|---|
| standard therapystandard therapy for advanced/metastatic breast cancer | Drug | – |
Primary outcome
Survival status at 3 years
Time frame: 3 years
percentage of patients still alive at 3 years
2 secondary outcomes
PFS
Time frame: 3 years
Survival status at 5 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Derived from this study: PubMed 34567118Han YQ, Yi ZB, Yu P, Wang WN, Ouyang QC, Yan M, Wang XJ, Hu XC, Jiang ZF, Huang T, Tong ZS, Wang SS, Yin YM, Li H, Yang RX, Yang HW, Teng YE, Sun T, Cai L, Li HY, Ouyang XN, He JJ, Liu XL, Yang SE, Qiao YL, Fan JH, Wang JY, Xu BH. Comparisons of Treatment for HER2-Positive Breast Cancer between Chinese and International Practice: A Nationwide Multicenter Epidemiological Study from China. J Oncol. 2021 Sep 15;2021:6621722. doi: 10.1155/2021/6621722. eCollection 2021.
- Derived from this study: PubMed 34472719Guo F, Yi Z, Wang W, Han Y, Yu P, Zhang S, Ouyang Q, Yan M, Wang X, Hu X, Jiang Z, Huang T, Tong Z, Wang S, Yin Y, Li H, Yang R, Yang H, Teng Y, Sun T, Cai L, Li H, Chen X, He J, Liu X, Yang S, Fan J, Qiao Y, Wang J, Xu B. Profile, treatment patterns, and influencing factors of anthracycline use in breast cancer patients in China: A nation-wide multicenter study. Cancer Med. 2021 Oct;10(19):6744-6761. doi: 10.1002/cam4.4215. Epub 2021 Sep 2.
- Derived from this study: PubMed 33643905Wu Y, Han Y, Yu P, Ouyang Q, Yan M, Wang X, Hu X, Jiang Z, Huang T, Tong Z, Wang S, Yin Y, Li H, Yang R, Yang H, Teng Y, Sun T, Cai L, Li H, Chen X, He J, Liu X, Yang S, Qiao Y, Fan J, Wang J, Xu B. Endocrine Therapy for Hormone Receptor-Positive Advanced Breast Cancer: A Nation-Wide Multicenter Epidemiological Study in China. Front Oncol. 2021 Feb 11;10:599604. doi: 10.3389/fonc.2020.599604. eCollection 2020.
- Derived from this study: PubMed 32700765Yi ZB, Yu P, Zhang S, Wang WN, Han YQ, Ouyang QC, Yan M, Wang XJ, Hu XC, Jiang ZF, Huang T, Tong ZS, Wang SS, Yin YM, Li H, Yang RX, Yang HW, Teng YE, Sun T, Cai L, Li HY, Chen X, He JJ, Liu XL, Yang SE, Wang JY, Fan JH, Qiao YL, Xu BH. Profile and outcome of receptor conversion in breast cancer metastases: a nation-wide multicenter epidemiological study. Int J Cancer. 2021 Feb 1;148(3):692-701. doi: 10.1002/ijc.33227. Epub 2020 Aug 19.
- 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.
Binghe Xu contact
Binghe Xu principal investigator
Chinese Academy of Medical Sciences
Youlin Qiao principal investigator
Chinese Academy of Medical Sciences
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Cancer, run by Chinese Academy of Medical Sciences at 19 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 2 inclusion and 1 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 Binghe Xu (syhiir@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival status at 3 years (time frame: 3 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 NCT03047889, which also lists 4 linked publications.
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 9 Feb 2017.