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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007166
Receipt No. R000008440
Scientific Title A phase II study of a low dose every 3 weeks Abraxane for metastatic or recurrent breast cancer.
Date of disclosure of the study information 2012/01/30
Last modified on 2018/02/04

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Basic information
Public title A phase II study of a low dose every 3 weeks Abraxane for metastatic or recurrent breast cancer.
Acronym A phase II study of a low dose every 3 weeks Abraxane for metastatic or recurrent breast cancer.
Scientific Title A phase II study of a low dose every 3 weeks Abraxane for metastatic or recurrent breast cancer.
Scientific Title:Acronym A phase II study of a low dose every 3 weeks Abraxane for metastatic or recurrent breast cancer.
Region
Japan

Condition
Condition metastatic or recurrent breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of tri-weekly low dose Abraxane for metastatic or recurrent breast cancer.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Feasibility of at least six treatment cycles of tri-weekly low dose Abraxane
Key secondary outcomes Progression free survival,Response rate, Toxicity

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 Patients receive 180mg of abraxane per squarer meter of body-surface area on day1 of every 21-day cycle

The patients continue therapy until disease progression or prohibitive toxic effects occur.

Registration period: Jan,2012-Dec,2015
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 Histologically confirmed metastatic breast cancer

Inoperative metastatic or recurrent breast cancer

Age from 20 to 65 years old: Prior treatment by chemotherapy (however, age from 65 to 75 years old
No previous treatment by chemotherapy is acceptable)

Performance status is 0,1,2.

The patient must have no carry-over of efficacy from any previous treatment
Surgery 4 weeks radiation therapy: 2 weeks
endocrine therapy 2weeks
chemotherapy 4 weeks

Required baseline laboratory data. (within 14 days of registration)
WBC 3,000mm3
Neu 1,500mm3
PLT100,000 mm3
Hb 9.0 gdL
ALT and AST ULN2.5
ALT and AST ULN2.5
T-Bil 1.5mgdL
serum creatine 1.5mgdL

Expected survival time more than 3 months

The patient has personally given written, informed consent to participate in this study

Key exclusion criteria With history of hypersensitivity reaction for paclitaxel and/or Albumin
.
With serious drug allergy

With infectious disease

With Pregnant or nursing women

With ECG abnormalities or heart failure with clinically problem

With Poorly controlled diabetes

With active another cancer

With widespread liver metastases or pulmonary lymphangitis with dyspnea

With brain metastasis with symptom

With dyspnea at rest (due to metastatic lung lesion and cardiovascular disease)


With pleural effusion, ascites, and pericardial effusion that need treat

Radiation therapy for chest

With Peripheral neuropathy greater than grade 2

With pulmonary fibrosis or pneumonitis

Cases who physician judged improper to entry this trial
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Yamamoto
Organization Yamaguchi University Graduate School of medicine
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, JAPAN
TEL 083-622-2264
Email syamamo@yamamguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Yamamoto
Organization Yamaguchi University Graduate School of medicine
Division name Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan
TEL 0836-22-2264
Homepage URL
Email syamamo@yamaguchi-u.ac.jp

Sponsor
Institute Department of Digestive Surgery and Surgical Oncology,Yamaguchi University Graduate School of medicine
Institute
Department

Funding Source
Organization Department of Digestive Surgery and Surgical Oncology,Yamaguchi University Graduate School of medicine
Organization
Division
Category of Funding Organization Other
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 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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 01 Month 30 Day
Last modified on
2018 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008440

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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