Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer

NCT04683770 | Unknown

• 1 other identifier: 2020-KY-063
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is aimed to explore a prospective observational clinical study on the efficacy prediction and survival prediction of HR + / HER2 - biomarkers detection in patients with advanced breast cancer. This study is a prospective, observational clinical study. We analyzed the incidence of biomarker mutations in HR + / HER2 - advanced breast cancer (stage IV), and the correlation between biomarkers and therapeutic efficacy, survival, and prognosis.

Conditions

Breast Cancer

Keywords

Breast Cancer; biomarker; prognosis

Outcome Measures

Primary Outcomes (1)

• Correlation between biomarkers and efficacy of tumor therapy

  explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.

  1 year

Secondary Outcomes (8)

• overall survival，OS

  2 year

• Complete remission, CR

  1 year

• Partial remission, PR

  1 year

• Disease stable, SD

  1 year

• Disease progression, PD

  1 year

Study Arms (1)

HR + / HER2 - advanced breast cancer

Eligibility Criteria

• Age: 18 Years - 80 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:

• Adult female patients (aged 18-80 years, including 18 and 80 years) with advanced breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
• Pathological examination confirmed that ER and/or PR were positive and HER-2 was negative (ER expression: immunohistochemical staining \> 1% of tumor cells; PR expression: immunohistochemical staining of tumor cells \> 1%; HER-2 negative: immunohistochemical staining of 0,1 +, or fish / CISH negative)
• No more than four systematic treatments have been used for advanced diseases
• It is expected that the patients can be followed up at least once after the treatment plan is formulated.
• The WHO physical status was 0-2 points, and the expected survival time was not less than 3 months;
• No more than four systematic treatment regimens have been received in the past for advanced diseases
• There was at least one measurable lesion (short diameter of lymph node ≥ 15mm) in imaging examination within 2 weeks before enrollment, and a conventional CT scan was performed. The diameter of spiral CT scan was more than or equal to 20 mm or more than 10 mm.
• Prior treatment-related toxicity should be reduced to NCI CTCAE (version 4.03) ≤ 1 degree (except for hair loss or other toxicity judged by the researcher as having no risk to the safety of patients)
• Within one week before admission, blood routine examination was basically normal: A. white blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L; B. neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L; C. platelet count (PLT) ≥ 100 × 10 \^ 9 / L;
• Within one week before admission, liver, and kidney function tests were basically normal (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × ULN; B. alanine aminotransferase and aspartate aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastases ≤ 5xuln); C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml/min；

You may not qualify if:

• The diagnosis of any other malignant tumor within 3 years before enrollment, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ after adequate treatment;
• Poor compliance or the situation that the researchers think is not suitable to be included in the study;
• Pregnant or lactating patients;
• Patients who had received transplantation before;
• Patients who had previously received stem cell therapy;
• Patients who have received any immunotherapy that may introduce exogenous DNA and other patients who may introduce exogenous DNA within 4 weeks;
• Have received more than four systematic treatments for advanced diseases;
• May interfere with the concomitant diseases or conditions involved in the study, or have any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection);

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat Sen Memorial Hospital，Sun Yat sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The object 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, second-generation sequencing, and detection of related biomarkers. The clinical total exome sequencing (4813 gene) kit developed by Illumina company was used for embryo line detection, and the system detection project used the system detection chip designed by the laboratory.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jianli Dr. Zhao, doctor

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianli Dr. Zhao, doctor

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: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)