Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
January 1, 2019 updated by: Li Huiping, Peking University Cancer Hospital & Institute
The anticipated objectives of this study are: 1) to understand the pathogenesis and molecular typing of breast cancer patients in China (mainly HER2 overexpression, triple negative and hormone receptor-positive patients) by detecting DNA and RNA in tumor tissue (fresh tissue or paraffin section), and to compare the similarities and differences between the western population and Chinese population; 2) plasma samples of patients with HER2 overexpression , hormone receptor-positive and triple negative (ER, PR, HER2 expression negative) were sequenced for ctDNA and ctRNA, to find out whether there are genes or gene sets related to therapeutic effect; 3) to study the specific changes of liquid molecular detection results according to the previous research results, and establish mathematical models to predict and monitor the effects of targeted therapy and endocrine therapy; 4) to compare liquid biopsy and imaging and clinical features in monitoring clinical therapeutic effect, and to elaborate the advantages and disadvantages of liquid biopsy and conventional imaging; 5) to provide molecular detection basis for follow-up clinical research and screening for targets of new drugs.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
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
-
-
Beijing
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Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Huiping LI, M.D.
-
-
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
Non-Probability Sample
Study Population
Patients of breast cancer in China mainly with HER2 overexpression, triple negative and hormone receptor-positive.
Description
Inclusion Criteria:
- patients with first treated or recurrent metastatic breast cancer, according to RECIST version 1.1 standard, confirmed by CT or MRI, have at least one measurable lesion.
- HER2 positive or triple negative patients; (IHC++, fish amplification)
- Patients with anti-HER2 treatment as first-line or not, and patients with HER2 positive can be treated with adjuvant therapy containing trastuzumab.
Exclusion Criteria:
-
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 |
Intervention / Treatment |
|---|---|
|
breast cancer with HER2 overexpression
|
Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
|
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hormone receptor-positive breast cancer
|
Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
|
|
triple negative breast cancer
|
Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline targeted mutation analysis of ctDNA
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
|
ctDNA copy number loss related with progress free survival(PFS)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
|
ctDNA copy number loss related with Overall survival(OS)
Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
|
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 20, 2017
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
December 29, 2018
First Submitted That Met QC Criteria
January 1, 2019
First Posted (Actual)
January 3, 2019
Study Record Updates
Last Update Posted (Actual)
January 3, 2019
Last Update Submitted That Met QC Criteria
January 1, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017KT40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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