UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007342 |
|---|---|
| Receipt number | 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 19:07:03 |
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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
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
imoto@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Breast Surgery, Kyorin University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008655
