UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017177 |
|---|---|
| Receipt number | R000019931 |
| Scientific Title | Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2019/02/04 18:19:02 |
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Basic information
Public title
Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Acronym
Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Scientific Title
Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Scientific Title:Acronym
Phase II study of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the efficacy and safety of Nab-paclitaxel plus S-1 followed by FEC as neoadjuvant chemotherapy for the operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response rate(ypT0/is ypN0)
Key secondary outcomes
adverse event, quasi pathological complete response rate, response rate, rete of breast conserving surgery, biomarker of chemotherapy, disease free survival
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
4 cycles of Nab-paclitaxel plus S-1 followed by 4 cycles of FEC100
Nab-Paclitaxel plus S-1
Nab-Paclitaxel(100mg/m2) day1,8,15, every 3 weeks
S-1(80mg/m2) 2-week administration followed by 1-week rest
every 3 weeks
FEC
5-FU 100mg/m2, epirubicin 100 mg/m2 and CPA 500 mg/m2 administered intravenously on day 1 of each 3-week cycle
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
1) Cytological confirmed breast cancer
2) Clinical Stage II-IIIA
3) Expected to radical cure by operation and neoadjuvant chemotherapy
4) Has measurable region
5) Age 20 or over
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) Adequate function of important organs (within 14 days before registaration)
1. WBC: >=3,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T-Bil <= ULN x 2.5
6. AST <= ULN x 1.5
7. ALT <= ULN x 1.5
8. Creatinin <= 1.5mg/dL
8) ECOG performance status 0-1
9) Written informed consent
Key exclusion criteria
1) History of hypersensitivity reaction
2) HER2 negative disease
3) Active double cancer
4) Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure.
5) Severe mental disorder
6) Sever bone marrow suppression, renal dysfunction, liver dysfunction
7) Has watery diarrhea
8) Active infection or potentiality infection
9) History of hypersensitivity for albumin
10) Grade2 or grater peripheral neuropathy
11)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
12)Judged ineligible based on physicians' decision
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Seki |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Breast Center
Zip code
Address
Shirokane5-9-1 Minato-ku, Tokyo
TEL
03-3444-6161
hirosuke@blue.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Seki |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Breast Center
Zip code
Address
Shirokane5-9-1 Minato-ku, Tokyo
TEL
03-3444-6161
Homepage URL
hirosuke@blue.ocn.ne.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
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
| 2015 | Year | 04 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019931
