UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009616
Receipt No. R000011281
Scientific Title Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Date of disclosure of the study information 2012/12/24
Last modified on 2012/12/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Acronym Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Scientific Title Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Scientific Title:Acronym Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or 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 evaluate maximum tolerated dose and recommended dose of Cyclophosphamide and Albumin-bound paclitaxel combination chemotherapy for metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determinate 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:600mg/m2 day1
Albumin-bound paclitaxel:150mg/m2-260mg/m2 day1 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 1Histological confirmed primary breast cancer
2Reccurent,metastatic breast cancer
3No prior chemotherapy for metastasis, the recurrent breast cancer
4The case that passes after treatment of the adjuvant chemotherapy more than 24 weeks
5HER2 negative.
6An age of 20 years to 75 years
7ECOG Performance Status is 0 or 1
8Patient with measurable disease
9Required baseline laboratory data
10Expected survival time more than 60 days
11Written informed consent
Key exclusion criteria 1allergy of the medication
2Serious complications
3Previous or current history of malignant neoplasm
4Clinically significant heart disease
5Peripheral neuropathy grade2 or greater
6Active infection
7Symptomatic brain metastasis
8Uncontrollable pleural effusion or ascites requiring
9During administraton of pentostatin
10With mental disorder which become problem on clinical practice
11Current pregnancy or lacation,or possibility of pregnancy
12Cases who physician judged improper to entry this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Narui
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57 Urafune-cho,Minami-ku,Yokohama City,232-0024,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57 Urafune-cho,Minami-ku,Yokohama City,232-0024,Japan
TEL 045-261-5656
Homepage URL
Email nri@gc5.so-net.ne.jp

Sponsor
Institute Yokohama City University Medical Center
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
2012 Year 12 Month 24 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 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
2012 Year 12 Month 24 Day
Last modified on
2012 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011281

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.