Clinical trial NCT03792529: Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
Official title: Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Targeted Therapy
Molecular Screening
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Predicine (Shanghai) Medical Technology Co., Ltd.
First posted: 2019-01-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of breast cancer in China mainly with HER2 overexpression, triple negative and hormone receptor-positive.

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Change from baseline targeted mutation analysis of ctDNA
timeFrame: 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
measure: ctDNA copy number loss related with progress free survival(PFS)
timeFrame: 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
measure: ctDNA copy number loss related with Overall survival(OS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Huiping Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao H, Zhang J, Zheng T, Liu X, Zhong J, Shao B, Dong X, Wang X, Du P, King BL, Jia S, Yu J, Li H. Identification of mutation patterns and circulating tumour DNA-derived prognostic markers in advanced breast cancer patients. J Transl Med. 2022 May 13;20(1):211. doi: 10.1186/s12967-022-03421-8.