UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015516 |
|---|---|
| Receipt number | 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 | 2019/07/17 10:33:57 |
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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
Name of lead principal investigator
| 1st name | Fumikata |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of breast oncology
Zip code
791-0280
Address
160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture 791-0280, Japan
TEL
089-999-1111
hfumikat@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Shinano |
Organization
CSPOR-BC
Division name
Secretariat
Zip code
101-0021
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
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
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
NHO Shikoku Cancer Center
Address
160 Ko Minamiumemoto Matsuyama Ehime JAPAN
Tel
089-999-1111
hfumikat@shikoku-cc.go.jp
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 24 | Day |
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
| 2019 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916
