UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Title of the study (Brief title)	The feasibility study of pharmacokinetics and immune response of T-DM1 in metastatic/recurrent HER2-positive breast cancer
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate a new technique to measure pharmacokinetics and immune response in breast cancer patients treated with T-DM1.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics and immune response of T-DM1
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	a) Pathologically confirmed breast cancer b) HER2-positive by IHC or ISH c) Locally advanced or metastatic/recurrent breast cancer d) Any prior treatment e) 20 y.o. and over f) ECOG performance status 0-2 g) Adequate interval from prior therapy h) Interval over 2w from prior radiotherapy i) Adequate baseline organ and marrow function as defined below: Platelet count >= 100,000mm3 Hemoglobin >= 7.0g/dL AST and ALT <= 2.5x ULN Serum bilirubin <= 1.5 x ULN j) Baseline left ventricular ejection fraction (LVEF) >= 50% by echocardiography k) Signed written informed consent
Key exclusion criteria	a) Brain metastasis with clinical symptoms b) Uncontrollable body fluid c) Concurrent serious disease or condition Active infection concurrent serious psychiatric disorder Ileus, breeding Uncontrollable angina and mycardial infarction within 3 months, severe heart disease with heart failure d) pregnant or lactating women e) Patient considered irrelevant by attending physician for the study
Target sample size	20

Research contact person
Name of lead principal investigator	Kenji Tamura
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	ketamura@ncc.go.jp

Public contact
Name of contact person	Akihiko Shimomura
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	ashimomu@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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 08 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	One year follow-up after completion of recruitment.

Management information
Registered date	2015 Year 08 Month 10 Day
Last modified on	2018 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021536