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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015516
Receipt No. R000017916
Scientific Title Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
Date of disclosure of the study information 2014/11/01
Last modified on 2018/11/01

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Basic information
Public title Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
Acronym ABROAD
Scientific Title Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
Scientific Title:Acronym ABROAD
Region
Japan

Condition
Condition metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate non-inferiority of low dose abraxane compared to current standard dose 260mg/m2 of abraxane in 1st or 2nd line chemotherapy for metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression-free survival(PFS)
Key secondary outcomes time to treatment failure(TTF), overall survival (OS), response rate (RR), disease control rate (DCR), adverse events, PROs/HRQoL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Abraxane 260mg/m2 (SD arm)
every 21 days, until disease progression
Interventions/Control_2 Abraxane 220mg/m2 (MD arm)
every 21 days, until disease progression
Interventions/Control_3 Abraxane 180mg/m2 (LD arm)
every 21 days, until disease progression
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 Male and Female
Key inclusion criteria 1) Histologically proven breast cancer.
2) One of the following conditions has to be met for a diagnosis of metastatic breast cancer.
* At presentation, the patients have distant metastasis.
* The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post-operative treatment); however, local recurrence is excluded.
3) The presence of at least one measurable lesion. However, sites treated by radiotherapy are not considered assessable lesions.
4) Performance status (ECOG scale): 0-1
5) Age of 20-75 years.
6) Adequate major organ functions within 14 days before enrollment., as defined below:
Neutrophil count < 3,000/mm3
Platelet count < 100,000/mm3
Hemoglobin < 9.0 g/dL
AST < 100 U/L
ALT < 100 U/L
Total bilirubin < 1.5 mg/dL
Serum creatinine < 1.5 mg/dL
7) Written informed consent.
Key exclusion criteria 1) Overexpression of human epidermal growth factor receptor 2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive.
2) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less).
3) Grade2 or greater peripheral neuropathy
4) Severe allergic history against medicines
5) Severe complications, e.g., lung fibrosis, interstitial pneumonitis, uncotrolable diabetes meritus, severe cardiac dysfunction, renal failure, liver failure, cerebral vascular disorder, ulcer requiring blood transfusion.
6) Concurrent active infections.
7) The presence of brain metastasis requiring treatment
8) Psychiatric disorder affecting to get informed consent
9) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 138

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Fumikata Hara
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of breast oncology
Zip code
Address 160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture 791-0280, Japan
TEL 089-999-1111
Email hfumikat@shikoku-cc.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name CSPOR-BC
Organization CSPOR-BC
Division name Secretariat
Zip code
Address 101 Gakkikaikan 2-18-21 Sotokanda Chiyoda, Tokyo, 101-0021
TEL 03-5294-7288
Homepage URL http://cspor-bc.or.jp/study/index.html
Email office-bc@cspor-bc.or.jp

Sponsor
Institute CSPOR-BC
Institute
Department

Funding Source
Organization TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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 四国がんセンター,国立がん研究センター東病院 など

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 Day

Related information
URL releasing protocol http://cspor-bc.or.jp/study/index.html
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
2014 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 16 Day
Last follow-up date
2019 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 24 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916

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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