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

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ClinicalTrials.gov Identifier: NCT04683770
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jianli Zhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study：Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
HR + / HER2 - advanced breast cancer


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between biomarkers and efficacy of tumor therapy [ Time Frame: 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 :
  1. overall survival，OS [ Time Frame: 2 year ]
    The time from the beginning of treatment to the death of the patient

  2. Complete remission, CR [ Time Frame: 1 year ]
    all target lesions disappeared, no new lesions appeared, and tumor markers were normal, which lasted for at least 4 weeks

  3. Partial remission, PR [ Time Frame: 1 year ]
    the diameter of target lesions diminished more than 30% and lasted for 4 weeks

  4. Disease stable, SD [ Time Frame: 1 year ]
    the sum of the maximum diameter of the target lesion is smaller than PR, or the increase is not up to PD

  5. Disease progression, PD [ Time Frame: 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

  6. Objective response rate , ORR [ Time Frame: 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

  7. Clinical benefit rate, CBR [ Time Frame: 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.

  8. Quality of life scale score，QoL [ Time Frame: 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)


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast Cancer
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);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683770


Contacts
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Contact: Jianli Dr. Zhao, doctor 86-20-34070870 zhaojli5@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat Sen Memorial Hospital，Sun Yat sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianli Zhao    020-34070870    zhaojli5@mail.sysu.edu.cn   
Contact: Ying Wang    020-34070499    wangy556@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Jianli Dr. Zhao, doctor Study Principal Investigator
More Information
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Responsible Party: Jianli Zhao, Attending Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04683770    
Other Study ID Numbers: 2020-KY-063
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianli Zhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Breast Cancer
biomarker
prognosis
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases