Breast CancerNCT03792529
Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
An observational study of Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- detect gene mutations of ctDNA and ctRNA
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients of breast cancer in China mainly with HER2 overexpression, triple negative and hormone receptor-positive.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Huiping LI, M.D.
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- detect gene mutations of ctDNA and ctRNA
- Keywords
- Targeted Therapy, Molecular Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detect gene mutations of ctDNA and ctRNAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer with HER2 overexpression | Not described Receives: Other: detect gene mutations of ctDNA and ctRNA | |
| hormone receptor-positive breast cancer | Not described Receives: Other: detect gene mutations of ctDNA and ctRNA | |
| triple negative breast cancer | Not described Receives: Other: detect gene mutations of ctDNA and ctRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline targeted mutation analysis of ctDNA
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
Measured: 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)
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
Measured: 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)
ctDNA sequenced with Illumina Sequencer and analyzing SNV and Indel in ctDNA by software.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start20 Jul 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Predicine (Shanghai) Medical Technology Co., Ltd.
- Responsible party
- Principal investigator, Li Huiping, Peking University Cancer Hospital & Institute
- Investigators
- Huiping Li, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792529
- Sponsor's protocol ID
- 2017KT40
- Status last verified
- Jan 2019
- First submitted
- 29 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35562750
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Targeted Therapy Related Molecular Screening Program for Patients of Breast Cancer in China
- ClinicalTrials.gov ID
- NCT03792529
- Acronym / sponsor ID
- 2017KT40
- Conditions
- Breast Cancer
- Keywords
- Targeted Therapy, Molecular Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Predicine (Shanghai) Medical Technology Co., Ltd.
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer with HER2 overexpression | – | Other: detect gene mutations of ctDNA and ctRNA |
| hormone receptor-positive breast cancer | – | Other: detect gene mutations of ctDNA and ctRNA |
| triple negative breast cancer | – | Other: detect gene mutations of ctDNA and ctRNA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of breast cancer in China mainly with HER2 overexpression, triple negative and hormone receptor-positive.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detect gene mutations of ctDNA and ctRNASamples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples. | Other | breast cancer with HER2 overexpression, hormone receptor-positive breast cancer, triple negative breast cancer |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 35562750Liao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiping Li principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiping Li, M.D. ((0086)13811012595, huipingli2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.