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

NCT04683757 | Unknown

• 1 other identifier: 2017-KY-19
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 2

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

Keywords

Breast Cancer; a Survival Prediction Model

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Progression Free Survival，PFS

  2 years

• 5-year survival rate

  5 years

Interventions

Establishment of a Survival Prediction Model OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

breast cancer

You may qualify if:

• At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
• ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
• 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
• Patients who are willing to receive follow-up treatment in the research center.

You may not qualify if:

• 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.
• Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
• Combined with other malignant tumors or had other malignant tumors in recent 5 years
• 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
• Patients with life expectancy less than 3 months

Sponsors & Collaborators

• Ying Wang: lead

Study Sites (2)

Sun Yat Sen Memorial Hospital，Sun Yat sen University

Guangzhou, Guangdong, 510000, China

COMPLETED

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

Guanzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The target of this study is to detect the gene mutation of tumor tissue or peripheral blood circulation tumor DNA of tumor patients. 10ml of tissue or fresh peripheral blood should be collected as the test sample and stored at room temperature. On the same day, it was sent to the "cell and molecular diagnosis center" of our hospital for DNA isolation and extraction, secondary sequencing, and detection of related biomarkers, such as erbB2 / TP53 / PIK3CA / ErbB4 / CCND1.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ying Dr. Wang, doctor

CONTACT

86-20-34070499; wangy556@mail.sysu.edu.cn

Jianli Zhao

CONTACT

86-20-34070870; zhaojli5@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: December 31, 2024
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)