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

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ClinicalTrials.gov Identifier: NCT03792529
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Predicine (Shanghai) Medical Technology Co., Ltd.
Information provided by (Responsible Party):
Li Huiping, Beijing Cancer Hospital

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.

Condition or disease Intervention/treatment
Breast Cancer Other: detect gene mutations of ctDNA and ctRNA

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
breast cancer with HER2 overexpression 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.

hormone receptor-positive breast cancer 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.

triple negative breast cancer 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of breast cancer in China mainly with HER2 overexpression, triple negative and hormone receptor-positive.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792529


Contacts
Contact: Huiping Li, M.D. (0086)13811012595 huipingli2012@hotmail.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Huiping LI, M.D.         
Sponsors and Collaborators
Beijing Cancer Hospital
Predicine (Shanghai) Medical Technology Co., Ltd.
Investigators
Principal Investigator: Huiping Li Beijing Cancer Hospital

Responsible Party: Li Huiping, Head of the department of breast oncology, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03792529     History of Changes
Other Study ID Numbers: 2017KT40
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Huiping, Beijing Cancer Hospital:
Targeted Therapy
Molecular Screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases