UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009155
Receipt No. 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 2018/06/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yusuke Tanigawara, PhD
Organization Keio University
Division name School of Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3847
Email tanigawara@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Tamura, MD, PhD
Organization National Cancer Center Hospital
Division name Department of Breast and Medical Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL 03-3542-2511
Homepage URL
Email ketamura@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Address
Tel
Email

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
Publication of results Published

Result
URL related to results and publications http://abstracts.asco.org/214/AbstView_214_222695.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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
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
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.