UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010945 |
|---|---|
| Receipt number | R000012740 |
| Scientific Title | Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2016/12/14 09:32:49 |
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Basic information
Public title
Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Acronym
Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Scientific Title
Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Scientific Title:Acronym
Phase I trial of weekly nab-paclitaxel plus cyclophosphamide for metastatic breast cancer
Region
| Japan |
Condition
Condition
advanced or metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine maximum tolerated dose and recommended dose of weekly nab-paclitaxel plus cyclophosphamide
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To determine maximum tolerated dose and recommended dose
Key secondary outcomes
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
Cyclophosphamide:600 mg / m2, day1
nab-paclitaxel:80-150 mg / m2, day1,8,15
every 3 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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Histrogical confirmed inoperable and metastatic breast cancer
2)HER2 negative confirmed by IHC or FISH
3)At least one measurable lesion
4)Performance status of 0 or 1
5)Age are 20-75 years old
6)Required baseline laboratory date within 14 days
WBC>=4000/mm3
Neu>=2000/mm3
Hb>=9.0g/dL
Plt>=100000/mm3
T-Bill=<1.5mg/dL
AST<=100IU/L
ALT<=100IU/L
Cr<=1.2mg/dL
7)Written informed consent
Key exclusion criteria
1)Received a taxane within 6 months in neoadjuvant or adjuvant chemotherapy before study treatment
2)Received chemotherapy for metastatic breast cancer (more than one regimen)
3)Pre-treatment paclitaxel, docetaxel, nab-paclitaxel for metastatic breast cancer
4)Received endocrine therapy within 1 week of the study treatment
5)Received irradiation within 2 weeks of the study treatment
6)Received surgery within 4 weeks of the study treatment
7)With symptomatic brain metastases
8)With grade2 or grater peripheral neuropathy, myalgia, arthralgia
9)Requiring pleural effusion, peritoneal effusion, pericardial effusion by drain
10)Undergoing (oral or intravenous) systemic continuous steroids administration
11) With serious complications (active infection, pulmonary fibrosis, diabetes, heart disease, renal failure, hepatic failure, B hepatitis, C hepatitis, HIV, etc.)
12) With a history of hypersensitivity for nab-paclitaxel, paclitaxel, albumin , cyclophosphamide and undergoing pentostatin administration, with serious bone marrow suppression, infectious diseases
13)With active double cancer
14) Pregnant or possibility of pregnant
15)Patients judged by the investigator as unfit to be enrolled in the study
the study treatment
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Ota |
Organization
Mitsui Memorial Hospital
Division name
Breast Endocrine Surgery
Zip code
Address
Kandaizumicho-1, Chiyoda-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Mitsui Memorial Hospital
Division name
Breast Endocrine Surgery
Zip code
Address
TEL
03-3862-9111
Homepage URL
Sponsor or person
Institute
Mitsui Memorial Hospital
Department of Breast Endocrine Surgery
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
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
| 2013 | Year | 06 | Month | 17 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012740
