UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of drug distributions in tissue section using mass imaging technology in patients with breast cancer
Title of the study (Brief title)	Analysis of drug distributions in tissue section using mass imaging technology in patients with 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	We consider the establishment and usefulness of the mass imaging technology approach to analyze the tissue distribution of the anti-neoplastic agents in patients with breast cancer.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We confirm the correlation between the distribution and effectiveness of anti-cancer agents in breast cancer.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Operation. Biopsy: We incise skin under local anesthesia, and perform a tumor biopsy by needle.
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. Histologically proven breast cancer patients b. Patients to perform surgery or biopsy for diagnosis, treatment, or research purposes, in S-1, capecitabine, bevacizumab, trastuzumab, paclitaxel, nab-paclitaxel, or tamoxifen have been administered or scheduled to administer as the standard treatment, c. Performance status (ECOG) 0, 1, 2 d. 20 years of age and older e. Patients with tumor tissue which is thought to be located in safely collected sites f. Written informed consent.
Key exclusion criteria	a. Patients with active infection b. Patients with other serious disease c. Patients with coagulation abnormalities or patients who are not possible to rest anticoagulants d. Patients with history of severe drug allergy e. Pregnant or nursing females f. Patients whose participation in the study is judged to be inappropriate by the attending doctor.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuichi Ando
Organization	Nagoya University Hospital
Division name	Clinical Oncology and Chemotherapy
Address	65 Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL	052-744-1903
Email	yando@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tomoya Shimokata
Organization	Nagoya University Graduate School of Medicine
Division name	Clinical Oncology and Chemotherapy
Address	65 Tsurumai-cho, Syowa-ku, Nagoya, Aichi
TEL	052-744-1903
Homepage URL
Email	tshimo@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department

Funding Source
Organization	Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Organization
Division
Category of Funding Organization	Self funding
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 09 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 28 Day
Anticipated trial start date	2013 Year 10 Month 28 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2016 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021898