UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005982 |
|---|---|
| Receipt number | 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 09:57:22 |
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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
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
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007077
