- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683770
Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
December 19, 2020 updated by: Jianli Zhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
An Observational Study:Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Sun Yat Sen Memorial Hospital,Sun Yat sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Breast Cancer
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
HR + / HER2 - advanced breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 year
|
overall survival,OS
Time Frame: 2 year
|
The time from the beginning of treatment to the death of the patient
|
2 year
|
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
|
1 year
|
Partial remission, PR
Time Frame: 1 year
|
the diameter of target lesions diminished more than 30% and lasted for 4 weeks
|
1 year
|
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
|
1 year
|
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
|
1 year
|
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
|
1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jianli Dr. Zhao, doctor, Study Principal Investigator
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ANTICIPATED)
July 1, 2021
Study Completion (ANTICIPATED)
July 1, 2022
Study Registration Dates
First Submitted
December 19, 2020
First Submitted That Met QC Criteria
December 19, 2020
First Posted (ACTUAL)
December 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 24, 2020
Last Update Submitted That Met QC Criteria
December 19, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-KY-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer