UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in partients with metastatic breast cancer
Title of the study (Brief title)	Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in partients with metastatic breast cancer
Region	Japan

Condition
Condition	metastic and recurrance breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to assess the efficary and safty of weekly nab-paclitaxel in combination with gemcitabine in Japanese partients with metastatic breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	PFS,OS,Safty

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	Nab-paclitaxel:125mg/m2 intravenously administred on day 1,8 every 3 weeks Gemcitabine:1000mg/m2 intravenously administred on day 1,8 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	Not applicable
Gender	Female
Key inclusion criteria	1.Histologically confirmed Breast cancer 2.Inoperative metastatic or recurrent breast cancer 3.Patients with evaluable lesion 4.Age >=20 5.No prior treatment for metastatic or recurrent breast cancer 6.Sufficient organ functions Hemoglobin >=9.0g/dl WBC >=4000/mm3 Neurtophils >=2000/mm3 Platelets >=100,000/mm3 Total bilirubin <=1.5mg/dl GOT and GPT < ULNx2.5 Creatinine <1.5mg/dl 7.Performance status 0-1 8.Patients who have passed the following periods from previous treatment Endocrinetherapy:7 days from the final administration Adjuvant:6 months from the final administration 9Written IC
Key exclusion criteria	1.Inflammatory and bilateral breast cancer 2.Active another cancer 3.History of hypersensitivity reaction 4. Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure 5.Neuropathy <= grade1 6. Radiation therapy for chest 7.Serious myeloablation 8.Infection 9.Pregnant or possibility pregnancy or nursing woman 10.Physician judged improper to entry this trial
Target sample size	40

Research contact person
Name of lead principal investigator	Syunsuke Magoshi
Organization	Toho University Omori Medical Center
Division name	Breast and Endocrine Surgery
Address	6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	magoshi@med.toho-u.ac.jp

Public contact
Name of contact person	Syunsuke Magoshi
Organization	Toho University Omori Medical Center
Division name	Breast and Endocrine Surgery
Address	6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	magoshi@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
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	2011 Year 09 Month 28 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
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	2011 Year 09 Month 28 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000007630