UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Acronym	Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Scientific Title	Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Scientific Title:Acronym	Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to determine predictive factors of nab-paclitaxel by evaluating the correlation with biomarker in the tumor tissues and clinical effect for early-stage or stage IV breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Correlativity of the biomarker and Response Rate
Key secondary outcomes	Rasponse rate,Pathological response rate, Safty

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 Nab-paclitaxel:100mg/m2 i.v weekly for 12 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Female
Key inclusion criteria	1.Histologically confirmed Breast cancer 2.Clinical stage2-4 3.Has measurable region 4.Age >=20 and 80=< 5.No prior surgery, radiation, chemotherapy and endcrinethrapy 6.Presence of measurable lesion 7.Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC >= 3000 /mm3 and <= 12,000 /mm3 Neu >= 1500 / mm3 Plt >= 75,000/mm3 T-Bil <= 2.5 times ULM AST<= ULNx2.5 ALT<= ULNx2.5 Creatinine <=1.5 mg/dL 8.Performance status 0-2 9.Written IC
Key exclusion criteria	1.History of hypersensitivity reaction 2.HER2 positive confirmed by IHC or FISH 3. Active another cancer 4.Other severe complications, such as infection, diarrhea, intestinal tract paralysis, ileus, uncontrollable diabetes,uncontrollable angina, myocardial infarction within 6 months, heart failure, Pulmonary fibrosis or interstitial pneumonia, cerebrovascular disorder 5.With symptomatic brain cancer 6.With mental disorder which become problem on clinical practice 7.With serious bone marrow suppression, a renal damage, a liver damage 8.With serious pleural effusion or ascites 9.With infection or febrile infection 10. Hypersensitivity reaction of nab-paclitaxel or paclitaxel 11.During administration of flucytosine, phenytoin, warfarin potassium 8. Physician judged improper to entry this trial
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Yasushi Middle name Last name Okamoto
Organization	Toho University School of Medicine, Medical Center, Ohashi Hospital
Division name	Breast cancer center
Zip code	1538515
Address	2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
TEL	03-3468-1251
Email	yok195@med.toho-u.ac.jp

Public contact
1st name of contact person	1st name YASUSHI Middle name Last name OKAMOTO
Organization	Toho University School of Medicine, Medical Center, Ohashi Hospita
Division name	Breast cancer center
Zip code	1538515
Address	2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
TEL	03-3468-1251
Homepage URL
Email	yok195@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine, Medical Center, Ohashi Hospital
Institute
Department

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)

IRB Contact (For public release)
Organization	Toho University School of Medicine, Medical Center, Ohashi Hospital
Address	2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
Tel	03-3468-1251
Email	secretary@oha.toho-u.ac.jp

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 12 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 10 Month 01 Day
Date of IRB	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 11 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 12 Month 11 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010936