UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007342
Receipt No. R000008655
Scientific Title Phase II study of tri-weekly administration of nanoparticle albumin-bound-paclitaxel for first-line chemotherapy in advanced and metastatic HER2- negative breast cancer
Date of disclosure of the study information 2012/02/27
Last modified on 2014/02/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of tri-weekly administration of nanoparticle albumin-bound-paclitaxel for first-line chemotherapy in advanced and metastatic HER2- negative breast cancer
Acronym Phase II study of Nab-paclitaxel treatment in HER2-negative breast cancer
Scientific Title Phase II study of tri-weekly administration of nanoparticle albumin-bound-paclitaxel for first-line chemotherapy in advanced and metastatic HER2- negative breast cancer
Scientific Title:Acronym Phase II study of Nab-paclitaxel treatment in HER2-negative breast cancer
Region
Japan

Condition
Condition advanced and metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical benefit and safety of tri-weekly administration nanoparticle albumin-bound -paclitaxel for advanced and metastatic HER2-negative breast cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Tumor response rate
Key secondary outcomes safety overall survival progression-free survival adverse events QOL

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 250 mg/m2 (i.v.) x every 3 weeks x 6 cycles or more
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
70 years-old >=
Gender Female
Key inclusion criteria 1 Histological diagnosis of invasive and HER2-negative breast cancer
2 Stage IV or recurrent breast cancer
3 No prior chemotherapy after diagnosis of metastases
4 Measurable disease
5 No treatment with radiation within 7 days or endocrine therapy within 14 days of the study. Any kind of primary chemotherapy or adjuvant chemotherapy at the diagnosis of operable breast cancer
6 Acceptable organ condition
7 ECOG PS of 0 to 2
8 A written informed consent
Key exclusion criteria Past history of viral B or C hepatitis
Interstitial pulmonary disease or its past history
Other invasive cancer
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Imoto
Organization Kyorin University Hospital
Division name Department of Breast Surgery
Zip code
Address 6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Isaka
Organization Kyorin University Hospital
Division name Department of Breast Surgery
Zip code
Address 6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL 0422-47-5511
Homepage URL http://www.kyorin-u.ac.jp/hospital/clinic/surgery03/center.shtml
Email imoto@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Breast Surgery, Kyorin University Hospital
Institute
Department

Funding Source
Organization Department of Breast Surgery, Kyorin University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 杏林大学付属病院 武蔵野赤十字病院 日野市立病院 佐々総合病院 青梅市立総合病院 公立福生病院 慈恵医大第三病院 複十字病院 東京医大八王子医療センター 公立昭和病院 多摩総合医療センター (すべて東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 27 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 No longer recruiting
Date of protocol fixation
2011 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2016 Year 07 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 02 Month 21 Day
Last modified on
2014 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008655

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.