Breast CancerNCT05544123
The Treatment Situation of Chinese County Population With Breast Cancer
An observational study of Breast Cancer and Breast Carcinoma, run by The First Affiliated Hospital of Xinxiang Medical College at 2 sites in China.
Trial summary
The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The purpose of this study is to be aware of the real-world data of the current breast cancer diagnosis and treatment model in the county. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Carcinoma, Breast Tumor
- What is being tested?
- pathological stage
- How many people
- 2,500 participants
- Where
- 2 sitesChina
- Study dates
- 29 Sep 2022to Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 2500 breast cancer patients will be recruited in this study. The entire subjects are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region). In order to acquire adequate treatment patterns choices in China county area. Data collection and analysis are needed in the corresponding population. Data collection and analysis are needed in the corresponding population. The entire subjects contain in this study are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region).
Who may be able to join
- Cohort 1
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HER2+ breast cancer
- Newly diagnosed or completed definitive early breast surgery
- Complete medical history information
- Cohort 2
Show all 20Show fewer
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HR+ HER2- breast cancer
- Newly diagnosed or completed definitive early breast surgery
- Complete medical history information
- Cohort 3
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HER2+ breast cancer
- De Novo or recurrent metastatic breast cancer
- Complete medical history information
- Cohort 4
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HR+ HER2- breast cancer
- De Novo or recurrent metastatic breast cancer
- Complete medical history information
Who cannot join
- Cohort 1
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 2
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 3
- Patients with HER2 + advanced breast cancer who have received more than 2 lines of therapy
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 4
- Patients with HR+ HER2- advanced breast cancer who have received more than 2 lines of therapy
- Participated in other Intervention drug clinical trials within 4 weeks before admission
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Ping Lu, Doctor, 13598722864, lupingdoctor@126.com
Yinghua M Ji, Master, 13663030446, 54234317@qq.com
- Recruiting
路平
Xinxiang, Henan, 453100
Ping Lu, 13598722864, lupingdoctor@126.com
About this study
Official title: A Multi-center, Observational Study to Describe the Treatment Situation of Chinese County Population With HER2+ & HR+/HER2- Breast Cancer
The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The purpose of this study is to be aware of the real-world data of the current breast cancer diagnosis and treatment model in the county. It aims to understand the gap between the county and the SOC in the diagnosis and treatment.
Read the detailed description
The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The patients will be divided into four cohorts by HR/HER2 status and early/late stage without prespecified minimum or maximum limit of patient number for each cohort.
The potential study subjects will be identified by the investigators by face-to-face visit. During this process approximately 2500 subjects will be enrolled in 1 year. All subjects will be sign informed consent and recorded for demographic characteristics, medical history, treatment history, treatment hospital, pathologic diagnosis, receptor status, therapeutic regimen, etc at the beginning of enrollment. Normally, there will be 4 visits for EBC and 6 visits for ABC in hospitals during yearlong follow-up period. All visits are according to the standard frequency of clinical follow-up. If the patient does not come to the hospital for follow-up on a regular basis, we will follow-up by telephone inquiries, etc.The potential study subjects will be identified by the investigators by face-to-face visit. During this process approximately 2500 subjects will be enrolled in 1 year. All subjects will be sign informed consent and recorded for demographic characteristics, medical history, treatment history, treatment hospital, pathologic diagnosis, receptor status, therapeutic regimen, etc at the beginning of enrollment. Normally, there will be 4 visits for EBC and 6 visits for ABC in hospitals during yearlong follow-up period. All visits are according to the standard frequency of clinical follow-up. If the patient does not come to the hospital for follow-up on a regular basis, we will follow-up by telephone inquiries, etc.
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumor
- Being tested
- pathological stage
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pathological stageOther
breast cancer molecular subtyping and pathological TNM stage
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 HER2+ EBC | newly diagnosed or completed definitive breast surgery Receives: Other: pathological stage | |
| Cohort 2 HR+ HER2- EBC | newly diagnosed or completed definitive breast surgery Receives: Other: pathological stage | |
| Cohort 3 HER2+ ABC | De novo or relapsed from adjuvant therapy Receives: Other: pathological stage | |
| Cohort 4 HR+ HER2- ABC | De novo or relapsed from adjuvant therapy Receives: Other: pathological stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
Different treatment patterns in each cohort
Measured: 1 year
Secondary outcomes (4)
the referral behavior in county
To describe the referral behavior in county (Among all patients)
Measured: 1 year
he relationship between recurrent risk and OFS, chemotherapy and OFS
To explore the relationship between recurrent risk and OFS, chemotherapy and OFS
Measured: 1 year
the duration of medical OFS in early breast cancer
To explore the duration of medical OFS in early breast cancer
Measured: 1 year
the duration of anti-HER2 therapy in advanced breast cancer
To explore the duration of anti-HER2 therapy in advanced breast cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start29 Sep 2022
- Primary completionAug 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544123
- Sponsor's protocol ID
- ESR-21-21505
- Status last verified
- Jan 2023
- First submitted
- 9 Sep 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Observational Study to Describe the Treatment Situation of Chinese County Population With HER2+ & HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT05544123
- Acronym / sponsor ID
- ESR-21-21505
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Sep 2022 (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.
The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The purpose of this study is to be aware of the real-world data of the current breast cancer diagnosis and treatment model in the county. It aims to understand the gap between the county and the SOC in the diagnosis and treatment.
Detailed description
The study is a multi-center, non-interventional, prospective observational study which enrols 2500 breast cancer patients from China county area. The patients will be divided into four cohorts by HR/HER2 status and early/late stage without prespecified minimum or maximum limit of patient number for each cohort.
The potential study subjects will be identified by the investigators by face-to-face visit. During this process approximately 2500 subjects will be enrolled in 1 year. All subjects will be sign informed consent and recorded for demographic characteristics, medical history, treatment history, treatment hospital, pathologic diagnosis, receptor status, therapeutic regimen, etc at the beginning of enrollment. Normally, there will be 4 visits for EBC and 6 visits for ABC in hospitals during yearlong follow-up period. All visits are according to the standard frequency of clinical follow-up. If the patient does not come to the hospital for follow-up on a regular basis, we will follow-up by telephone inquiries, etc.The potential study subjects will be identified by the investigators by face-to-face visit. During this process approximately 2500 subjects will be enrolled in 1 year. All subjects will be sign informed consent and recorded for demographic characteristics, medical history, treatment history, treatment hospital, pathologic diagnosis, receptor status, therapeutic regimen, etc at the beginning of enrollment. Normally, there will be 4 visits for EBC and 6 visits for ABC in hospitals during yearlong follow-up period. All visits are according to the standard frequency of clinical follow-up. If the patient does not come to the hospital for follow-up on a regular basis, we will follow-up by telephone inquiries, etc.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 HER2+ EBC | – | Other: pathological stagenewly diagnosed or completed definitive breast surgery |
| Cohort 2 HR+ HER2- EBC | – | Other: pathological stagenewly diagnosed or completed definitive breast surgery |
| Cohort 3 HER2+ ABC | – | Other: pathological stageDe novo or relapsed from adjuvant therapy |
| Cohort 4 HR+ HER2- ABC | – | Other: pathological stageDe novo or relapsed from adjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 2500 breast cancer patients will be recruited in this study. The entire subjects are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region). In order to acquire adequate treatment patterns choices in China county area. Data collection and analysis are needed in the corresponding population. Data collection and analysis are needed in the corresponding population. The entire subjects contain in this study are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region).
Key inclusion criteria (20 listed)
- Cohort 1
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HER2+ breast cancer
- Newly diagnosed or completed definitive early breast surgery
- Complete medical history information
Key exclusion criteria (7 listed)
- Cohort 1
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 2
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 3
- Patients with HER2 + advanced breast cancer who have received more than 2 lines of therapy
- Participated in other Intervention drug clinical trials within 4 weeks before admission Cohort 4
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 |
|---|---|---|
| pathological stagebreast cancer molecular subtyping and pathological TNM stage | Other | Cohort 1 HER2+ EBC, Cohort 2 HR+ HER2- EBC, Cohort 3 HER2+ ABC, Cohort 4 HR+ HER2- ABC |
Primary outcome
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
Time frame: 1 year
Different treatment patterns in each cohort
4 secondary outcomes
the referral behavior in county
Time frame: 1 year
he relationship between recurrent risk and OFS, chemotherapy and OFS
Time frame: 1 year
the duration of medical OFS in early breast cancer
Time frame: 1 year
the duration of anti-HER2 therapy in advanced breast cancer
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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.
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
2 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 Cancer and Breast Carcinoma, run by The First Affiliated Hospital of Xinxiang Medical College at 2 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 20 inclusion and 7 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023.