Breast NeoplasmsNCT01169792
Study of Cytochrome P450 Polymorphisms (CYP2D6, CYP3A4/5 and CYP2C19) in Breast Cancer Patients
An observational study of Breast Neoplasms and Survival Analysis, run by Yonsei University at 2 sites in South Korea.
Trial summary
The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen. The investigators want to evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and analyze the association between the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Survival Analysis, Antineoplastic Agents
- What is being tested?
- tamoxifen
- How many people
- Not given
- Where
- 2 sitesSouth Korea
- Study dates
- Start not givento not given
- 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
- All sexes
- Adult, Older adult
Study population: Breast cancer survivors who underwent surgery at Severance hospital, Yonsei University Health System.
Who may be able to join
- age ≥ 18 years
- Breast cancer patients who underwent surgery
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
Jin-Gu, Busan, , 614-735
Department of Surgery, Yonsei University College of Medicine
Saedaemoon-gu, Seoul, 120-752
About this study
Official title: Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment
The genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.
The investigators want to
- evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and
- analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.
- Being tested
- tamoxifen
- Keywords
- Tamoxifen, Cytochrome P-450 CYP2D6, Polymorphism, Single nucleotide, Antineoplastic Agents, Hormonal
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifenDrug
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Breast cancer patients who underwent surgery with or without chemotherapy, endocrine therapy and/or radiation therapy. The patients are categorized according to the genetic polymorphisms or the activity score of the cytochrome P450 metabolism. Receives: Drug: tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients
The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients
The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients
Secondary outcomes (3)
The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Retrospective
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University
- Investigators
- Byeong-Woo Park, M.D.,ph.D., Study chair, Department of Surgery and Brain Korea 21 Project for Medical Science, Yonsei University College of MedicineJae-Gook Shin, M.D.,ph.D., Study chair, Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169792
- Sponsor's protocol ID
- 4-2009-0483
- Status last verified
- Oct 2009
- First submitted
- 23 Jul 2010
- Last updated
- 26 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Genetic Polymorphisms of CYP2D6 and Outcomes in Breast Cancer Patients With Tamoxifen Treatment
- ClinicalTrials.gov ID
- NCT01169792
- Acronym / sponsor ID
- 4-2009-0483
- Keywords
- Tamoxifen, Cytochrome P-450 CYP2D6, Polymorphism, Single nucleotide, Antineoplastic Agents, Hormonal
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Inje University
- First posted
- 26 Jul 2010 (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 genetic polymorphisms of the cytochrome P450 may influence on the metabolism of tamoxifen.
The investigators want to
- evaluate the frequency or incidence of the genetic polymorphisms of cytochrome P450 subfamilies(CYP2D6, CYP3A4/5 and CYP2C19) in breast cancer patients, and
- analyze the association between the genetic polymorphisms of cytochrome P450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Drug: tamoxifenBreast cancer patients who underwent surgery with or without chemotherapy, endocrine therapy and/or radiation therapy. The patients are categorized according to the genetic polymorphisms or the activity score of the cytochrome P450 metabolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors who underwent surgery at Severance hospital, Yonsei University Health System.
Key inclusion criteria (2 listed)
- age ≥ 18 years
- Breast cancer patients who underwent surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| tamoxifen | Drug | Breast cancer patients |
Primary outcome
The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients
The frequency of the genetic polymorphisms of CYP3A4/5 in breast cancer patients
The frequency of the genetic polymorphisms of CYP2C19 in breast cancer patients
3 secondary outcomes
The association between the genetic polymorphisms of CYP2D6 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP3A4/5 and outcomes in breast cancer patients with tamoxifen therapy
The association between the genetic polymorphisms of CYP2C19 and outcomes in breast cancer patients with tamoxifen therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
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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.
Byeong-Woo Park, M.D.,ph.D. study chair
Department of Surgery and Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine
Jae-Gook Shin, M.D.,ph.D. study chair
Department of Pharmacology and Pharmacogenomics Research Center, Inje University College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Survival Analysis, run by Yonsei University at 2 sites 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 2 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: finished, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of the genetic polymorphisms of CYP2D6 in breast cancer patients. 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?
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 26 Jul 2010.