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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010945
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Mitsui Memorial Hospital
Department of Breast Endocrine Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012740

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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