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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005982
Receipt No. R000007077
Scientific Title Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Date of disclosure of the study information 2011/07/15
Last modified on 2012/01/17

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Basic information
Public title Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Acronym Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Scientific Title Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Scientific Title:Acronym Phase II study of weekly 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 investigate the efficacy and safety of weekly Nab-paclitaxel for metastatic breast cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate
Key secondary outcomes Adverse event

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 100 mg/m2 administered weekly intravenously over 30 minutes
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

Not applicable
Gender Female
Key inclusion criteria 1) Histologically confirmed primary breast cancer
2) Clinically confirmed metastatic breast cancer
3) With measurable lesion
4) Received no previous chemotherapy, or only two regimen
5) Age >= 20 years
6) ECOG performance status of 0 or 1
7) Required baseline laboratory parameters (within 14 days before registration)
Hb >= 9.0g/dL
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 10.0x104/mm3
T-Bil <= 1.5mg/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Cre <= 1.5mg/dL
8) A life expectancy of more than 90 days
9) Written informed consent
Key exclusion criteria 1) Allergy of nab-paclitaxel, albumin or paclitaxel
2) Serious complication
3) Synchronous or metachronous (within 5 years) double cancers
4) Abnormal ECG
5) Congestive heart failure, coronary artery diseases, uncontrollable arrhythmia or past history of myocardial infarction or angina pectoris within 6 months
6) Relapsed within 12 months (or during its treatment) after taxane-based neoadjuvant and adjuvant chemotherapy. Resistant to taxane-based neoadjuvant chemotherapy
7) Fully recovered from surgical within 4 weeks before registration
8) Received radiotherapy or neoadjuvant and adjuvant chemotherapy within 3 weeks before registration
9) Received endocrine therapy within 2 weeks before registration
10) Received ratiotherapy for more than 30% of hematopoietic bone marrow
11) Peripheral neuropathy grade 2 or greater
12) Active infection
13) Symptomatic brain metastasis
14) Un-controlled pleural effusion and ascites
15) Long-term corticosteroid therapy
16) Mental disorder
17) Pregnancy, breast feeding or wish of future bearing
18) Patients considered inappropriate by the study investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Oura
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Homepage URL
Email

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Minami Wakayama Medical Center
Hashimoto Municipal Hospital
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 15 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
2011 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 15 Day
Last modified on
2012 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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