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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683757
• Other study ID #: 2017-KY-19
• Status: Recruiting
• 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
• Email: wangy556[@]mail.sysu.edu.cn
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

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

China, 

Outcome

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