Breast Cancer
Conditions
Keywords
Targeted Therapy, Molecular Screening
Brief summary
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.
Interventions
OTHERdetect gene mutations of ctDNA and ctRNA
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.
Sponsors
Predicine (Shanghai) Medical Technology Co., Ltd.
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline targeted mutation analysis of ctDNA | 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. |
| ctDNA copy number loss related with progress free survival(PFS) | 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. |
| ctDNA copy number loss related with Overall survival(OS) | 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. |
Countries
China
Contacts
Primary ContactHuiping Li, M.D.
Outcome results
None listed