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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04683757
Other study ID # 2017-KY-19
Secondary ID
Status Recruiting
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2024

Study information

Verified date December 2020
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Ying Dr. Wang, doctor
Phone 86-20-34070499
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility

Status Recruiting
Enrollment 288
Est. completion date December 31, 2024
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. At the time of signing the informed consent form, 18 years old = 70 years old, female 2. ER positive breast cancer confirmed by pathology: ER positive (= 1%) by immunohistochemistry 3. 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 4. Patients who are willing to receive follow-up treatment in the research center. Exclusion Criteria: 1. 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. 2. Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions 3. Combined with other malignant tumors or had other malignant tumors in recent 5 years 4. 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 5. Patients with life expectancy less than 3 months

Study Design

Related Conditions & MeSH terms


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


Country Name City State
China Sun Yat Sen Memorial Hospital,Sun Yat sen University Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guanzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Ying Wang

Country where clinical trial is conducted



Type Measure Description Time frame Safety issue
Primary overall survival,OS The time from the beginning of treatment to the death of the patient 5 years
Primary 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 Progression Free Survival,PFS The time from the beginning of treatment to the progression or death of the patient. 2 years
Secondary 5-year survival rate the survival rate in 5 years 5 years
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