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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Establishment of a Survival Prediction Model

• Study Type: Observational
• Enrollment (Anticipated): 288

Contacts and Locations

• Study Contact: Name: Jianli Zhao; Phone Number: 86-20-34070870; Email: zhaojli5@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Completed
      • Sun Yat Sen Memorial Hospital，Sun Yat sen University
    • Guanzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Ying Wang; Phone Number: 86-020-34070870; Email: wangy556@mail.sysu.edu.cn
      • Contact: Jianli Zhao; Phone Number: 86-020-34070499; Email: zhaojli5@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

breast cancer

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ying Wang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; a Survival Prediction Model
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2017-KY-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No