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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022931
Receipt No. R000026428
Scientific Title PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2018/05/23

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Basic information
Public title PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Acronym PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Scientific Title PhaseII study of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the operable breast cancer
Scientific Title:Acronym PhaseII study of Nab-paclitaxel followed by EC 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 is to assess the efficacy and safety of Nab-paclitaxel followed by EC as neoadjuvant chemotherapy for the breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate
Key secondary outcomes Response rate, rate of breast conserving surgery, frequency and degree of adverse events, remains rate of peripheral neuropathy, QOL survey, Correlation of the QOL survey results and the pCR rate and the response rate

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 weekly Nab-paclitaxel followed by 4 cycles of EC100
weekly nab-Paclitaxel
(HER2 negative)
Nab-Paclitaxel(80mg/m2) day1,8,15, every 4 weeks
(HER2 positive)
Nab-Paclitaxel(80mg/m2) day1,8,15
Trastuzumab 2mg/kg day1,8,15,22
(4 mg/kg for the initial dosing)
every 4 weeks

EC
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 I-III B
3) Expected to radical operation of post chemotherapy
4) Has measurable region
5) Age 20 or over
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) Performance Status 0-1
8) Adequate function of important organs(within 14 days before registration)
WBC >=4,000/mm3
Neutrophil >=2,000/mm3
Platelet >=10.0 x 104/mm3
Hemoglobin >=9.0g/dL
AST <=100 IU/L
ALT <=100 IU/L
T-Bil <=1.5mg/dL
Creatinin <=1.5mg/dL

Key exclusion criteria 1) History of hypersensitivity reaction
2) Active double cander
3) Other severe complications, such as infections, diarrhea, uncontrolled angina, myocardial infarction within 6 months, heart failure.
4) Case of contraindication of this drug
5) Patients with peripheral nerve symptoms
6) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
7) Judged ineligible based on physicians' decision
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Sakata
Organization Rakuwakai Otowa Hospital
Division name Breast oncology department
Zip code
Address Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan
TEL +81-75-593-4111
Email Rakuwadr1198@rakuwadr.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Sakata
Organization Rakuwakai Otowa Hospital
Division name Breast oncology department
Zip code
Address Chinjicho2 Yamashina-ku, Kyoto city, Kyoto, Japan
TEL +81-75-593-4111
Homepage URL
Email Rakuwadr1198@rakuwadr.com

Sponsor
Institute Rakuwakai Otowa Hospital
Breast oncology department
Institute
Department

Funding Source
Organization Rakuwakai Otowa 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
2016 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 06 Month 28 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026428

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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