UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study for safety and efficacy of low dose nab-paclitaxel
Title of the study (Brief title)	Cohort study of low dose nab-paclitaxel
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	The objective of this study is to estimate safety and efficacy of low dose tri-weekly nab-paclitaxel (175mg/m2) in metastatic breast cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety
Key secondary outcomes	Time to progression Overall response rate Overall survival

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 is administered by drip infusion over 30 minutes in day 1 of 21 days cycle.
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	80 years-old >
Gender	Female
Key inclusion criteria	1) Histologically diagnosed female breast cancer patients 2) Inoperable or recurrent breast cancer patients 3) Age moer than 20 and less than 80 years old 4) Performance status 0 or 1 (ECOG) 5) Never treated with paclitaxel for metastatic disease. 6) Adequate major organ functions. WBC more than 4000/mm3 and less than 12000/mm3 Neutrophil more than 2000/mm3 Platelet more than 100000/mm3 Hemoglobin more than 9.0 g/dL AST, ALT less than 100 IU/L Total bilirubin less than 1.5 mg/dL Creatinine less than 1.5 mg/dL Normal ECG 7) The patients that an agreement of perticipation was obtained in a document
Key exclusion criteria	1) Past history of hypersensitivity for human serum albumin 2) Infectious disease that required systemic therapy 3) History of a severe heart disease 4) Poorly controlled diabetes mellitus 5) Peptic ulcer or gastrointestinal hemorrhage 6) Symptomatic brain metastsis 7) Pregnant, Lactating or possibility of pregnancy 8) History of drug allergy that may influenced with this treatment 9) In addition, the case that a investigator judged to be inadequate
Target sample size	20

Research contact person
Name of lead principal investigator	Tsutomu Takashima
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Surgical Oncology
Address	1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL	06-6645-3838
Email	tsutomu-@rd5.so-net.ne.jp

Public contact
Name of contact person	Tsutomu Takashima
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Surgical Oncology
Address	1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL	06-6645-3838
Homepage URL
Email	tsutomu-@rd5.so-net.ne.jp

Sponsor
Institute	Department of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgical Oncology Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
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	大阪市立大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 25 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 05 Month 30 Day
Anticipated trial start date	2011 Year 07 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 25 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007805