Breast CancerNCT02591966
Genetic Alteration After Systemic Treatment in 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 effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. The patients who receive neoadjuvant systemic treatments: 2. The patients who have distant metastatic sites at first and recur from surgery: 3. The patients who are going to receive first-line chemotherapy:
Who may be able to join
- Patients older than 20 years
- Patients with histologically confirmed breast cancer at three disease status
- Patients who are going to receive neoadjuvant chemotherapy with feasible biopsy site.
- Patients who recur from curative surgery and have distant metastasis with feasible biopsy site. ; Patients must have received adjuvant chemotherapy after curative surgery.
- Patients who are going to first-line palliative chemotherapy with feasible biopsy site.
- Patients with PS ECOG 0 - 2
Show all 13Show fewer
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Written informed consent form
- Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to study as defined below:
- Haemoglobin ≥9.0 g/L (transfusion allowed)
- White blood cells (WBC) > 3 x 109/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
Who cannot join
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
- Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Yeon Hee Park, MD, Ph.D, 82-2-3410-3459, yeonh.park@samsung.com
About this study
The purpose of this study is to investigate effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer.
Read the detailed description
Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.
The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy
- 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 |
|---|---|---|
| Biomarker group | 1. The patients who receive neoadjuvant systemic treatments: 2. The patients who have distant metastatic sites at first and recur from surgery: 3. The patients who are going to receive first-line chemotherapy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic profiling will be assessed by tissue sampling and blood.
Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients.
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (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
- Other
- 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, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591966
- Sponsor's protocol ID
- 2014-11-015
- Status last verified
- Jan 2018
- First submitted
- 26 Oct 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Alteration After Systemic Treatment in Breast Cancer
- ClinicalTrials.gov ID
- NCT02591966
- Acronym / sponsor ID
- 2014-11-015
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Oct 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 effects of systemic treatments on genomic profiles in patients with breast cancer and to compare genomic profiling between premenopausal and postmenopausal women by systemic treatments in breast cancer.
Detailed description
Prospective single arm trial using three patients' cohorts. One-hundred patients for each cohort and a total of 300 patients (600 biopsy samples) will be entered to this trial.
The hypothesis is that genomic alterations measured by CancerSCAN and cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be different between pre- and post-menopausal women and would be predictive biomarkers for each cohort according to pre- and post-menopausal status. Three groups of patients will be recruited:
- The patients who receive neoadjuvant systemic treatments:
- The patients who have distant metastatic sites at first and recur from surgery:
- The patients who are going to receive first-line chemotherapy
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker group | – | –1. The patients who receive neoadjuvant systemic treatments: 2. The patients who have distant metastatic sites at first and recur from surgery: 3. The patients who are going to receive first-line chemotherapy: |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The patients who receive neoadjuvant systemic treatments: 2. The patients who have distant metastatic sites at first and recur from surgery: 3. The patients who are going to receive first-line chemotherapy:
Key inclusion criteria (13 listed)
- Patients older than 20 years
- Patients with histologically confirmed breast cancer at three disease status
- Patients with PS ECOG 0 - 2
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- Written informed consent form
Key exclusion criteria (2 listed)
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.
- Double primary cancer (except for any cancer in remission for > 5 years, cervix cancer in situ, basal cell cancer in situ, any in situ cancers that are resected)
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
Genomic profiling will be assessed by tissue sampling and blood.
Time frame: 2year
Tissue and blood will be tested for CancerSCAN, cfDNA, WES, WTS, FACS, cytokine and immunologic signature analysis platform.NAC to study the multiscale relationships among DCE-MRI features, NGS data, and pathologic response to NAC and to evaluate the role of radiogenomics in predicting pathologic response of the patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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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 13 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 18 Jan 2018. 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 Yeon Hee Park, MD, PH.D (82-2-3410-3459, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic profiling will be assessed by tissue sampling and blood. (time frame: 2year). 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 18 Jan 2018.