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

• Conditions: Breast Cancer

• Registration Number: NCT04683770
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2020-12-19
• Last Update Submitted: 2020-12-19
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between biomarkers and efficacy of tumor therapy	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Partial remission, PR	1 year	the diameter of target lesions diminished more than 30% and lasted for 4 weeks
Clinical benefit rate, CBR	1 year	according to recist1.1 criteria, the proportion of patients with Cr or PR or SD ≥ 24 weeks in the total number of evaluable patients.
overall survival，OS	2 year	The time from the beginning of treatment to the death of the patient
Disease stable, SD	1 year	the sum of the maximum diameter of the target lesion is smaller than PR, or the increase is not up to PD
Disease progression, PD	1 year	the sum of the maximum diameter of the target lesion increased by at least 20%, and its absolute value increased by at least 5 mm, New lesions are also considered as PD
Complete remission, CR	1 year	all target lesions disappeared, no new lesions appeared, and tumor markers were normal, which lasted for at least 4 weeks
Quality of life scale score，QoL	1 year	The quality of life score of patients during treatment was analyzed（FACT-B）. Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale)
Objective response rate , ORR	1 year	according to recist1.1 criteria, the proportion of patients whose best remission is CR or PR in the total number of evaluable patients

Trial Locations

Locations (1)

Sun Yat Sen Memorial Hospital，Sun Yat sen University; 🇨🇳 Guangzhou, Guangdong, China