UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009155 |
|---|---|
| Receipt number | R000010735 |
| Scientific Title | Tamoxifen Response by CYP2D6 Genotype-Based Treatment in Patients with Metastatic or Recurrent Breast Cancer |
| Date of disclosure of the study information | 2012/10/20 |
| Last modified on | 2022/07/06 13:46:10 |
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Basic information
Public title
Tamoxifen Response by CYP2D6 Genotype-Based Treatment in Patients with Metastatic or Recurrent Breast Cancer
Acronym
TARGET-1 study
Scientific Title
Tamoxifen Response by CYP2D6 Genotype-Based Treatment in Patients with Metastatic or Recurrent Breast Cancer
Scientific Title:Acronym
TARGET-1 study
Region
| Japan |
Condition
Condition
Hormone receptor-positive metastatic or recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This phase II trial is studying to evaluate an application of tamoxifen dose adjustment based on CYP2D6 genotypes for treatment with patients in hormone receptor-positive metastatic or recurrent breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free rate at 6 months after the patient randomization
Key secondary outcomes
1) Response rate (CR+PR)
2) Clinical benefit (CR+PR + SD for longer than 6 months)
3) Relationship between trough levels of tamoxifen, endoxifen, 4-hydroxytamoxifen and N-desmethyltamoxifen at steady state and efficacy and/or adverse reactions
4) Exploration of factors affecting the response
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CYP2D6 wt/wt : 20mg/day for 24 weeks
Interventions/Control_2
CYP2D6 wt/V or V/V : 20mg/day for 24 weeks
Interventions/Control_3
CYP2D6 wt/V or V/V : 40mg/day for 24 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Metastatic or recurrent breast cancer
2) Estrogen-receptor positive
3) Patients who are planning to undergo tamoxifen treatment for the primary treatment breast cancer
4) Patients having measurable target lesions
5) ECOG performance status (PS) 0-1
6) Patients having no severely impaired main organs and marrow
7) Patients who are expected to survive more than 6 months after the first registration day
8) Patients must receive an adequate explanation of the trial before enrollment and sign a written informed consent document
Key exclusion criteria
1) HER2 status positive
2) Prior endocrine therapy for recurrent or metastatic disease
3) Prior chemotherapy for recurrent or metastatic disease
4) Patients having active double cancer
5) Patients having CNS metastasis
6) Patients receiving continuous systemic administration of steroids
7) Patients receiving prohibited concomitant medications
8) Patients having difficulty to enroll to the study for psychiatric reasons
9) Patients who are pregnant (or might be pregnant), nursing, or those who will not use contraceptive methods
10) Other cases determined as being unsuitable by the investigators
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanigawara |
Organization
Keio University, School of Medicine
Division name
Department of Clinical Pharmacokinetics and Pharmacodynamics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3847
tanigawara@a7.keio.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tamura |
Organization
National Cancer Center Hospital
Division name
Department of Breast and Medical Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL
03-3542-2511
Homepage URL
ketamura@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
RIKEN
IRB Contact (For public release)
Organization
RIKEN
Address
1-7-22 Suehirocho, Tsurumi-ku, Yokohama
Tel
045-503-9111
yokohama-web@riken.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
doi: 10.1200/JCO.19.01412.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1200/JCO.19.01412.
Number of participants that the trial has enrolled
186
Results
Between December 2012 and July 2016, 186 patients were enrolled in Japan.
Results date posted
| 2022 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of 184 evaluable patients, 136 carried wt/V or V/V, and 48 carried wt/wt.
Participant flow
136 with wt/V or V/V were randomly assigned to either the ID arm (n = 70) or RD arm (n = 66), and 48 with wt/wt were not randomly assigned and continued taking 20 mg of tamoxifen daily.
Adverse events
The incidence of adverse events, including hot flush and hypertriglyceridemia (common tamoxifen-related adverse events), did not differ significantly between the ID and RD
arms.
Outcome measures
In patients with wt/V or V/V, the PFS rates at 6 months did not differ significantly between the ID arm (67.6%; 95% CI,56.5% to 78.8%) and the RD arm (66.7%; 95% CI, 55.0% to 78.3%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010735
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