Breast CancerNCT04683757
The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
An observational study of Breast Cancer, run by Ying Wang at 2 sites in China.
Trial summary
This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Establishment of a Survival Prediction Model
- How many people
- 288 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2020to 31 Dec 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer
Who may be able to join
- At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
- ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
- Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
- Patients who are willing to receive follow-up treatment in the research center.
Who cannot join
- ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
- Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
- Combined with other malignant tumors or had other malignant tumors in recent 5 years
- Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
- Patients with life expectancy less than 3 months
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Completed
Sun Yat Sen Memorial Hospital，Sun Yat sen University
Guangzhou, Guangdong, 510000
- Recruiting
Sun Yat-sen Memorial Hospital， Sun Yat-sen University
Guanzhou, Guangdong, 510000
Ying Wang, 86-020-34070870, wangy556@mail.sysu.edu.cn
Jianli Zhao, 86-020-34070499, zhaojli5@mail.sysu.edu.cn
About this study
Official title: A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.
- Conditions
- Breast Cancer
- Being tested
- Establishment of a Survival Prediction Model
- Keywords
- Breast Cancer, a Survival Prediction Model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishment of a Survival Prediction ModelOther
a nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival，OS
The time from the beginning of treatment to the death of the patient
Measured: 5 years
Tumor specific survival time, CSS
The follow-up started from the first day of confirmed recurrence and metastasis. The end point of follow-up was the death caused by tumor related causes.
Measured: 5 years
Secondary outcomes (2)
Progression Free Survival，PFS
The time from the beginning of treatment to the progression or death of the patient.
Measured: 2 years
5-year survival rate
the survival rate in 5 years
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 posted24 Dec 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2021 (estimated)
- Study completion31 Dec 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683757
- Sponsor's protocol ID
- 2017-KY-19
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2020
- Last updated
- 24 Dec 2020
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04683757
- Acronym / sponsor ID
- 2017-KY-19
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, a Survival Prediction Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Ying WangUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Dec 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.
This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer
Key inclusion criteria (4 listed)
- At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
- ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
- Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
- Patients who are willing to receive follow-up treatment in the research center.
Key exclusion criteria (5 listed)
- ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
- Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
- Combined with other malignant tumors or had other malignant tumors in recent 5 years
- Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
- Patients with life expectancy less than 3 months
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 |
|---|---|---|
| Establishment of a Survival Prediction Modela nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer | Other | – |
Primary outcome
overall survival，OS
Time frame: 5 years
The time from the beginning of treatment to the death of the patient
Tumor specific survival time, CSS
Time frame: 5 years
The follow-up started from the first day of confirmed recurrence and metastasis. The end point of follow-up was the death caused by tumor related causes.
2 secondary outcomes
Progression Free Survival，PFS
Time frame: 2 years
5-year survival rate
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 24 Dec 2020.
- 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.
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, run by Ying Wang 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 4 inclusion and 5 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 24 Dec 2020. 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?
Contact Ying Dr. Wang, doctor (86-20-34070499, wangy556@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，OS (time frame: 5 years). The study lists 2 primary outcomes in all. 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 24 Dec 2020.