UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027216 |
|---|---|
| Receipt number | R000031143 |
| Scientific Title | Phase II study of nab-paclitaxel combined with S-1 in patients with early breast cancer:A multicenter clinical trial |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2017/05/01 20:07:55 |
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Basic information
Public title
Phase II study of nab-paclitaxel combined with S-1 in patients with early breast cancer:A multicenter clinical trial
Acronym
nab-paclitaxel + S-1 for early breast cancer
Scientific Title
Phase II study of nab-paclitaxel combined with S-1 in patients with early breast cancer:A multicenter clinical trial
Scientific Title:Acronym
nab-paclitaxel + S-1 for early breast cancer
Region
| Japan |
Condition
Condition
early breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of preoperative chemotharapy with S-1/nab-Paclitaxel follwed by epirubicin(doxorubicin)/cyclophosphamide for early breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathological complete response rate (ypT0/is ypN0)
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
Administrate 4 cycles of nab-Paclitaxel and S-1 therapy.
Nab-paclitaxel (220 mg/m2) intravenously on day 1 of each 3 weeks.S-1 given orally twice daily for 14 consecutive days, followed by a 7-day rest.
After 4 cycles of nab-Paclitaxel and S-1 therapy, adminiatrate 4 cycles of EC(AC)therapy.Operation is to be performed after chemotherapy.
For patients with HER2 positive breast cancer, trastuzumab intravenousy on day 1 of each 3-weeks in nab-Paclitaxel and S-1 therapy.
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
(1)Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (Stage IIA-Stage IV)and tumor size is 2cm or larger.
(2)Age between 20 to 75 years old.
(3)ECOG performance status (PS):0-1
(4)A survival expectancy of 6 months or longer.
(5)Results from a laboratory test meet the following
A)Leukocyte count is >=3,500/mm3 and <=12,000/mm3
B)Neutrophil count is >=2000/mm3
C)Platelet >=100,000/mm3
D)Hemoglobin >=9g/dl
E)Serum creatinine <= *2 of ULN
F)Ccr>=60ml/min
G)Total bilirubin <= 1.5mg/dl
H)AST/ALT <= *1.5 of ULN
(6)Signed written informed concent.
Key exclusion criteria
(1)DCIS or breast cancer wiht micro invasion.
(2)Patients with contraindication for any agents necessary in the planned treatment
(3)Male
(4)Women who are pregnant, lactating or with childbearing potential.
(5)Patients with a history of chemotherapy, endocrinetherapy or radiotherapy.
(6)Multiple primary cancer.
(7)Serious complications(diabetes infection or mental disorder)
(8)Serious complications with cardiac function
(9)Patients with serious edema
(10)Hypersensitivity to any agents necessary in the planned treatment.
(11)Ineligible based on decision of a investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
The University of Tokushima Graduate School
Division name
Depertment of Thoracic, Endocrine surgery and Oncology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503
TEL
088-633-7143
tangoku@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masami Morimoto |
Organization
The University of Tokushima Graduate School
Division name
Depertment of Thoracic, Endocrine surgery and Oncology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503
TEL
088-633-7143
Homepage URL
twop8air@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School
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
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
| 2017 | Year | 05 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | 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
| 2017 | Year | 05 | Month | 01 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031143
