Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China

Breast Cancer Clinical Trial

Official title:

Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792529
• Other study ID #: 2017KT40
• Status: Recruiting
• Start date: July 20, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Beijing Cancer Hospital
• Contact: Huiping Li, M.D.
• Phone: (0086)13811012595
• Email: huipingli2012[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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:

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• detect 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Predicine (Shanghai) Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline targeted mutation analysis of ctDNA	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
Primary	ctDNA copy number loss related with progress free survival(PFS)	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
Primary	ctDNA copy number loss related with Overall survival(OS)	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