The Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Establishment of a Survival Prediction Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Establishment of a Survival Prediction Model|a nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival，OS | The time from the beginning of treatment to the death of the patient | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival，PFS | The time from the beginning of treatment to the progression or death of the patient. | 2 years | 
| 5-year survival rate | the survival rate in 5 years | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, a Survival Prediction Model