Clinical trial NCT04683770: Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
Official title: An Observational Study：Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer
biomarker
prognosis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer

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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. 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)
3. No more than four systematic treatments have been used for advanced diseases
4. It is expected that the patients can be followed up at least once after the treatment plan is formulated.
5. The WHO physical status was 0-2 points, and the expected survival time was not less than 3 months;
6. No more than four systematic treatment regimens have been received in the past for advanced diseases
7. 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.
8. 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)
9. 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;
10. 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；

Exclusion Criteria:

1. 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;
2. Poor compliance or the situation that the researchers think is not suitable to be included in the study;
3. Pregnant or lactating patients;
4. Patients who had received transplantation before;
5. Patients who had previously received stem cell therapy;
6. Patients who have received any immunotherapy that may introduce exogenous DNA and other patients who may introduce exogenous DNA within 4 weeks;
7. Have received more than four systematic treatments for advanced diseases;
8. 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);

Primary outcomes:
measure: Correlation between biomarkers and efficacy of tumor therapy
timeFrame: 1 year
Secondary outcomes:
measure: overall survival，OS
timeFrame: 2 year
measure: Complete remission, CR
timeFrame: 1 year
measure: Partial remission, PR
timeFrame: 1 year
measure: Disease stable, SD
timeFrame: 1 year
measure: Disease progression, PD
timeFrame: 1 year
measure: Objective response rate , ORR
timeFrame: 1 year
measure: Clinical benefit rate, CBR
timeFrame: 1 year
measure: Quality of life scale score，QoL
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital，Sun Yat sen University
state: Guangdong
Study officials:
affiliation: Study Principal Investigator
name: Jianli Dr. Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References: