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

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04683757
• Lead Sponsor: Ying Wang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-19
• Last Update Submitted: 2020-12-19
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-01-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 288

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival，OS	5 years	The time from the beginning of treatment to the death of the patient
Tumor specific survival time, CSS	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.

Secondary Outcome Measures

Name	Time	Method
5-year survival rate	5 years	the survival rate in 5 years
Progression Free Survival，PFS	2 years	The time from the beginning of treatment to the progression or death of the patient.

Trial Locations

Locations (2)

Sun Yat-sen Memorial Hospital， Sun Yat-sen University; 🇨🇳 Guanzhou, Guangdong, China

Sun Yat Sen Memorial Hospital，Sun Yat sen University; 🇨🇳 Guangzhou, Guangdong, China