Breast CancerNCT02597179
Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically conrfirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age) with feasible biopsy site.
Who may be able to join
- Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
- HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
- Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
- Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
- Age ≥ 21 years
- Written informed consent
Who cannot join
- No feasible biopsy site
- No written informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-Gu, 135-710
Young-Hyuck Im, MD, Ph.D, 82-2-3410-3445, imyh00@skku.edu
About this study
The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.
Read the detailed description
The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer, Young Breast Cancer | Patients with feasible biopsy site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2012
- Primary completionJul 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Hyuck Im, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597179
- Sponsor's protocol ID
- 2012-08-065
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2015
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer
- ClinicalTrials.gov ID
- NCT02597179
- Acronym / sponsor ID
- 2012-08-065
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- 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 purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.
Detailed description
The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer, Young Breast Cancer | – | –Patients with feasible biopsy site. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically conrfirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age) with feasible biopsy site.
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
- HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
- Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
- Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
- Age ≥ 21 years
Key exclusion criteria (2 listed)
- No feasible biopsy site
- No written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
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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.
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 Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 2 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 1 May 2017. 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 South Korea. 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 Young-hyuck Im, MD, Ph.D (82-2-3410-3445, imyh00@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Mutated Genes and/or Abnormal Gene expression and/or Different Immune signature That Affect to Treatment Outcome. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2017.