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

NCT ID: NCT04683757

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 288 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Establishment of a Survival Prediction Model

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ying Wang

OTHER

Sponsor Role: lead

Responsible Party

Ying Wang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sun Yat Sen Memorial Hospital，Sun Yat sen University

Guangzhou, Guangdong, China

Site Status: COMPLETED

Sun Yat-sen Memorial Hospital， Sun Yat-sen University

Guanzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Dr. Wang, doctor

Role: CONTACT

wangy556@mail.sysu.edu.cn

86-20-34070499

Jianli Zhao

Role: CONTACT

zhaojli5@mail.sysu.edu.cn

86-20-34070870

Facility Contacts

Ying Wang

Role: primary

wangy556@mail.sysu.edu.cn

86-020-34070870

Jianli Zhao

Role: backup

zhaojli5@mail.sysu.edu.cn

86-020-34070499

Other Identifiers

2017-KY-19

Identifier Type: -

Identifier Source: org_study_id