Breast NeoplasmsASTRRA-CYP2D6NCT00973037
CYP2D6 Genotype on the Clinical Effect of Tamoxifen
An observational study of Breast Neoplasms and Tamoxifen, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Neoplasms, Tamoxifen, Genotype
- What is being tested?
- Tamoxifen
- How many people
- 922 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Apr 2016
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: young women(≤45 years) with hormone-sensitive breast cancer who remain in premenopause or regain menstruation after chemotherapy
Who may be able to join
- The patient must sign the informed consent form.
- The patient must sign the informed consent of genotype screening test.
- The patient must be between 18 years old and 45 years old who can make a decision independently.
- Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.(The type of mastectomy performed, number of axillary nodes removed, number of axillary nodes found positive, and tumor size must be included on the CRFs. For patients who have more than one discrete tumor masses should be measured and reported on the CRFs.)
- Patients must be within 3 months after the last cycle of chemotherapy.
- Patients must have the history of normal menstruation prior to the start of chemotherapy.
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- Stage I, II or III
- Woman, less than or equal to 45 years of age
- The test result of the estrogen receptor is positive.
- WHO performance status 0, 1 or 2.
- Patients who were treated with cytotoxic chemotherapy in pre or post surgery. Permissible prior chemotherapy; currently locally available and approved standard chemotherapy in the adjuvant or neoadjuvant setting: e.g., AC(Doxorubicin/cyclophosphamide) followed by taxane, AC(Doxorubicin/cyclophosphamide), TA(Docetaxel/ Doxorubicin), FAC(5-fluorouracil/ doxorubicin / cyclophosphamide) or others.
- Adequate hematological function defined by hemoglobin 10g/dl, neutrophil count 1.5 X 10 9/L and platelets 100 X 10 9/L.
- Adequate hepatic function defined by AST and ALT 2.5 X upper limit of normal. Alkaline phosphatase 5 X upper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine < 175 mmol/L.
Who cannot join
- The test result of the estrogen receptor is negative or unknown.
- Patients with the history of hysterectomy or oophorectomy.
- Sarcomas or squamous cell carcinomas of the breast are not eligible.
- Patients with malignancies(other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin.
- Investigational drugs given within the previous 4 weeks.
- Patients with thrombocytopenia (platelets < 100 X 10 9/L or on anti-coagulant therapy(contra-indicated due to risk of bleeding with i.m. injection of Zoladex).
- Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy.
- Patients who are pregnant or lactating are ineligible.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hopital
Seoul, 136-705
Eun Sook Lee, MD, PhD, 82-2-920-6744, eslee@korea.ac.kr
Eun Sook Lee, MD, PhD
About this study
Official title: Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study
The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).
- Conditions
- Breast Neoplasms, Tamoxifen, Genotype, CYP2D6
- Being tested
- Tamoxifen
- Keywords
- Breast neoplasms, Tamoxifen, Genotype, CYP2D6
- 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
Tamoxifen 20mg qd
| Study group | Role | What they receive |
|---|---|---|
| CYP2D6 | CYP2D6 genotype Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival(DFS)
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 922 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea, Korean Breast Cancer Study Group
- Investigators
- Eun Sook Lee, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973037
- Sponsor's protocol ID
- AN09020
- Acronym
- ASTRRA-CYP2D6
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT00973037
- Acronym / sponsor ID
- ASTRRA-CYP2D6 / AN09020
- Conditions
- Breast Neoplasms, Tamoxifen, Genotype, CYP2D6
- Keywords
- Breast neoplasms, Tamoxifen, Genotype, CYP2D6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 922 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea, Korean Breast Cancer Study Group
- Study start
- Mar 2009
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 9 Sep 2009 (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 the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYP2D6 | – | Drug: TamoxifenCYP2D6 genotype |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- young women(≤45 years) with hormone-sensitive breast cancer who remain in premenopause or regain menstruation after chemotherapy
Key inclusion criteria (13 listed)
- The patient must sign the informed consent form.
- The patient must sign the informed consent of genotype screening test.
- The patient must be between 18 years old and 45 years old who can make a decision independently.
- Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.(The type of mastectomy performed, number of axillary nodes removed, number of axillary nodes found positive, and tumor size must be included on the CRFs. For patients who have more than one discrete tumor masses should be measured and reported on the CRFs.)
- Patients must be within 3 months after the last cycle of chemotherapy.
Key exclusion criteria (8 listed)
- The test result of the estrogen receptor is negative or unknown.
- Patients with the history of hysterectomy or oophorectomy.
- Sarcomas or squamous cell carcinomas of the breast are not eligible.
- Patients with malignancies(other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin.
- Investigational drugs given within the previous 4 weeks.
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 |
|---|---|---|
| TamoxifenTamoxifen 20mg qd | Drug | CYP2D6 |
Primary outcome
Disease-free survival(DFS)
Time frame: 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
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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.
Eun Sook Lee, MD, PhD principal investigator
Korea University Anam Hospital
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 Neoplasms and Tamoxifen, run by Korea University Anam Hospital 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 8 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 9 Sep 2009. 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 Eun Sook Lee, MD, PhD (82-2-920-6744, eslee@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival(DFS) (time frame: 5years). 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 9 Sep 2009.