Breast CancerNCT02063906
Prognostic Relevance of Biological Subtype in Breast Cancer
An observational study of Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 202 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received curative surgery for stage I-III breast cancer between January 2004 and September 2008 and had available immunohistochemistry profiles.
Who may be able to join
- patients who received curative surgery
- stage I-III breast cancer
- between January 2004 and September 2008
- had available immunohistochemistry profiles.
Who cannot join
- age <18 years old
- microinvasive carcinoma of breast
Trial locations and contacts
1 site in 1 country.
Young-Hyuck Im, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
Young-Hyuck Im, MD, PhD, +82-2-3410-3445, yh00.im@samsung.com
About this study
Official title: Prognostic Relevance of Biological Subtype Overrides That of TNM Staging in Breast Cancer: Discordance Between Stage and Biology
Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.
Read the detailed description
Identified patients who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. Primary outcomes were recurrence-free survival (RFS) and overall survival (OS).
- 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 |
|---|---|---|
| Breast cancer stage I-III | who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
was measured from the first date of diagnosis of breast cancer to the date of death or the last follow-up visit
Measured: 1 year
Secondary outcomes (1)
Recurrence-free survival
was defined as the time from the date of curative resection to the date when breast cancer recurred, irrespective of locoregional recurrences including ipsilateral and contralateral breast recurrences or distant metastases.
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 posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2018 (estimated)
- Study completionMay 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 202 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
- Investigators
- Young-Hyuck Im, Pf, Principal investigator, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063906
- Sponsor's protocol ID
- 2014-02-045
- Status last verified
- Apr 2017
- First submitted
- 12 Feb 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- 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
- Prognostic Relevance of Biological Subtype Overrides That of TNM Staging in Breast Cancer: Discordance Between Stage and Biology
- ClinicalTrials.gov ID
- NCT02063906
- Acronym / sponsor ID
- 2014-02-045
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 17 Feb 2014 (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.
Recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. The aim of this study was to compare the prognostic relevance of the TNM staging system and intrinsic subtype in breast cancer patients who received curative surgery.
Detailed description
Identified patients who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. Primary outcomes were recurrence-free survival (RFS) and overall survival (OS).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer stage I-III | – | –who received curative surgery for stage I-III breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (HR) status, human epidermal growth factor receptor 2 (HER2) status, and Ki 67 staining at Samsung Medical Center from January 2004 to September 2008. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received curative surgery for stage I-III breast cancer between January 2004 and September 2008 and had available immunohistochemistry profiles.
Key inclusion criteria (4 listed)
- patients who received curative surgery
- stage I-III breast cancer
- between January 2004 and September 2008
- had available immunohistochemistry profiles.
Key exclusion criteria (2 listed)
- age <18 years old
- microinvasive carcinoma of breast
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
Overall survival
Time frame: 1 year
was measured from the first date of diagnosis of breast cancer to the date of death or the last follow-up visit
1 secondary outcome
Recurrence-free survival
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.
Young-Hyuck Im, MD, PhD contact
Young-Hyuck Im, Pf principal investigator
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
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 4 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, PhD (yh00.im@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (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.