UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Title of the study (Brief title)	Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate tolerared dose and recommended dose of Gemcitabine and nab-Paclitaxel combination chemotherapy for metastatic breast cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To determinate maximum tolerated dose and recommended dose
Key secondary outcomes	To determinate pharmacokinetics of nab-Paclitaxel and to validate feasibility

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Medicine
Interventions/Control_1	Gemcitabine:1250mg/m2 day1,8 nab-Paclitaxel:180mg/m2-260mg/m2 day1 every 3 weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	1)Histrogical confirmed primary breast cancer 2)Clinically confirmed metastatic breast cancer 3)HER2 negative confirmed by IHC or FISH 4)Age are 20-75 years old 5)None primary treatment with Paclitaxel and Gemcitabine *More than 6 months from Neo-adjuvant or adjuvant chemotherapy by paclitaxel or Gemcitabine 6)Required baseline primary treastment More than 4 weeks from surgery More than 2weeks from radiotherapy or endocrine therapy 7)Performance status of 0 or 1 8)Required baseline laboratory date WBC:4000/mm3-12000/mm3 Neu:>=4000/mm3 Plt:>=100000/mm3 Hb:>=9.0g/dL ALT and AST:<2.5 times of nomal range in institute T-Bil:<=1.5mg/dL Cr:<=1.5mg/dL 9)Expected survival time:more than 3 months 10)Written informed consent
Key exclusion criteria	1)Allergy of the Gemcitabine or nab-Paclitaxel 2)Contraindication to treatment with Gemcitabine or nab-Paclitaxel 3)With sever complications ex.)with incontrollable diabetes,with infection,mental disorder which become problem on clinical practice 4)During pregnancy or lactation 5)With extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea 6)With active double cancer 7)With symptomatic brain cancer 8)HBs antigen is positive 9)With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease 10)With pulmonary fibrosis or pneumonitis 11)With dyspnea at rest 12)With uncontrolled pleural effusion, peritoneal effusion, pericardial effusion 13)With grade 2 or grater peripheral neuropathy 14)Patients judged by the investigator as unfit to be enrolled in the study
Target sample size	9

Research contact person
Name of lead principal investigator	Naruto Taira
Organization	Okayama University Hospital
Division name	Breast and endocrical surgery
Address	2-5-1 Shikata-machi Kita-ku Okaya-shi
TEL	086-235-7265
Email	ntaira@md.okayama-u.ac.jp

Public contact
Name of contact person	Naruto Taira
Organization	Okayama University Hospital
Division name	Breast and endocrical surgery
Address	2-5-1 Shikata-machi Kita-ku Okaya-shi
TEL	086-235-7265
Homepage URL
Email	ntaira@md.okayama-u.ac.jp

Sponsor
Institute	Okayama Univesity Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	2012 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 12 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2014 Year 05 Month 15 Day
Date of closure to data entry	2014 Year 05 Month 27 Day
Date trial data considered complete	2014 Year 05 Month 27 Day
Date analysis concluded	2014 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/27316438
Results
Other related information

Management information
Registered date	2012 Year 10 Month 09 Day
Last modified on	2016 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010642