UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009526 |
|---|---|
| Receipt number | R000010936 |
| Scientific Title | Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study) |
| Date of disclosure of the study information | 2012/12/11 |
| Last modified on | 2019/04/25 16:25:49 |
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Basic information
Public title
Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Acronym
Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Scientific Title
Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Scientific Title:Acronym
Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to determine predictive factors of nab-paclitaxel by evaluating the correlation with biomarker in the tumor tissues and clinical effect for early-stage or stage IV breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Correlativity of the biomarker and Response Rate
Key secondary outcomes
Rasponse rate,Pathological response rate, Safty
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
Nab-paclitaxel
Nab-paclitaxel:100mg/m2 i.v weekly for 12 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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Histologically confirmed Breast cancer
2.Clinical stage2-4
3.Has measurable region
4.Age >=20 and 80=<
5.No prior surgery, radiation, chemotherapy and endcrinethrapy
6.Presence of measurable lesion
7.Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC >= 3000 /mm3 and <= 12,000 /mm3
Neu >= 1500 / mm3
Plt >= 75,000/mm3
T-Bil <= 2.5 times ULM
AST<= ULNx2.5
ALT<= ULNx2.5
Creatinine <=1.5 mg/dL
8.Performance status 0-2
9.Written IC
Key exclusion criteria
1.History of hypersensitivity reaction
2.HER2 positive confirmed by IHC or FISH
3. Active another cancer
4.Other severe complications, such as infection, diarrhea, intestinal tract paralysis, ileus, uncontrollable diabetes,uncontrollable angina, myocardial infarction within 6 months, heart failure, Pulmonary fibrosis or interstitial pneumonia, cerebrovascular disorder
5.With symptomatic brain cancer
6.With mental disorder which become problem on clinical practice
7.With serious bone marrow suppression, a renal damage, a liver damage
8.With serious pleural effusion or ascites
9.With infection or febrile infection
10. Hypersensitivity reaction of nab-paclitaxel or paclitaxel
11.During administration of flucytosine, phenytoin, warfarin potassium
8. Physician judged improper to entry this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Okamoto |
Organization
Toho University School of Medicine, Medical Center, Ohashi Hospital
Division name
Breast cancer center
Zip code
1538515
Address
2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
TEL
03-3468-1251
yok195@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | YASUSHI |
| Middle name | |
| Last name | OKAMOTO |
Organization
Toho University School of Medicine, Medical Center, Ohashi Hospita
Division name
Breast cancer center
Zip code
1538515
Address
2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
TEL
03-3468-1251
Homepage URL
yok195@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine, Medical Center, Ohashi Hospital
Institute
Department
Personal name
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
Toho University School of Medicine, Medical Center, Ohashi Hospital
Address
2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan
Tel
03-3468-1251
secretary@oha.toho-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
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 | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010936
