UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022628
Receipt number R000014055
Scientific Title Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy
Date of disclosure of the study information 2016/06/06
Last modified on 2018/06/11 13:10:50

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Basic information

Public title

Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy

Acronym

C-GENT study

Scientific Title

Prospective Clinical Study to Clarify the Relationship between CYP2D6 Genotype and the Therapeutic Effects of Preoperative Tamoxifen Therapy

Scientific Title:Acronym

C-GENT study

Region

Japan Asia(except Japan)


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Investigation of association between CYP2D6 variants and change in Ki67 labeling index after treatment with tamoxifen

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in Ki-67 labeling index after tamoxifen treatment

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


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

Male and Female

Key inclusion criteria

Patients who meet all the following criteria are eligible:
1)Patients who are histopathologically diagnosed with invasive breast cancer by biopsy, etc.;
2)Estrogen receptor-positive (the percentage of positive cells is 10% or more by immunohistological methods);
3)Stage I to IIIA;
4)Her2 negative (2+ and FISH-negative or 1+ or less);
5)Age when the treatment is initiated: 21 years or older;
6)Negative pregnancy test for patients who are in the reproductive age group;
7)Tissue specimens for measurement of Ki67 are available before initiating treatment;
8)Patients who are fully informed of and understand preoperative tamoxifen therapy properly before participation in this study, and subsequently submit their voluntary written informed consent to receive the therapy.

Key exclusion criteria

Patients who meet any of the following criteria are excluded from this clinical study:
1)Non-invasive cancer;
2)Renal dysfunction (dialysis patients with serum creatinine 2.5 mg/dL);
3)Patients with severe hepatic dysfunction (AST, ALT, and total bilirubin levels are all 1.5 or more times the institutional reference range);
4)Patients who are considered to have difficulty in complying with the procedures, observations, etc. specified in the protocol;
5)Patients who are considered to be inappropriate as a subject of this study by the investigator.

Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Zembutsu

Organization

National Cancer Center Research Institute

Division name

Division of Genetics

Zip code


Address

Tsukiji 5-1-1, Chuou-ku, TOKYO

TEL

03-3542-2511

Email

hzenbuts@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Zembutsu

Organization

National Cancer Center Research Institute

Division name

Division of Genetics

Zip code


Address

Tsukiji 5-1-1, Chuou-ku, TOKYO

TEL

03-3542-2511

Homepage URL


Email

hzenbuts@ncc.go.jp


Sponsor or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

2016 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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 05 Month 06 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Change in Ki-67 labeling index after tamoxifen therapy


Management information

Registered date

2016 Year 06 Month 06 Day

Last modified on

2018 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014055


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name