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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010685
Receipt No. R000012456
Scientific Title Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
Date of disclosure of the study information 2013/05/17
Last modified on 2013/05/10

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Basic information
Public title Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
Acronym Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
Scientific Title Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
Scientific Title:Acronym Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
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 EC Followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases
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 clinical response rate, pathological response rate, rete of breast conserving surgery, adverse event

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 EC followed by 4 cycles of tri-weekly Nab-paclitaxel
[EC]
epirubicin 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle
[Nab-paclitaxel]
Nab-paclitaxel 260 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
70 years-old >=
Gender Female
Key inclusion criteria 1)Histologically confirmed primary breast cancer
2)Clinical stage T1-3,>=N1,M0
3)Expected to radical cure by operation and neoadjuvant chemotherapy
4)At least one measurable lesion
5)Age >=20 and <= 70
6)No prior surgery, radiation, chemotherapy and endocrine therapy
7)adequate function of important organs (within 14 days before registaration)
1. Hemoglobin: >=9.0g/dL
2. WBC: >=4,000/mm3 or Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. T-Bil <= 1.5mg/dL
5. AST <= ULN x 2.5
6. ALT <= ULN x 2.5
7. Creatinin <= 1.5mg/dL
8. Adequate baseline cardiac function on Electrocardiography
8)ECOG performance status 0-1
9)written informed consent
10)Judged eligible based on physicians' decision
Key exclusion criteria 1)History of hypersensitivity reaction
2)Active another cancer
3)Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure.
4)Severe mental disorder
5)Sever bone marrow suppression, renal dysfunction, liver dysfunction
6)Body cavity fluid
7)Active infection or potentiality infection
8)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
9)Judged ineligible based on physicians' decision
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maki Nakai
Organization Saitama Medical Center,
Saitama Medical University
Division name Division of breast and endocrine Surgery
Zip code
Address Kamoda 1981, Kawagoe-shi, Saitama 350-8550, Japan
TEL 049-228-3464
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saitama Medical Center,Saitama Medical University
Division name Division of breast and endocrine Surgery
Zip code
Address
TEL 049-228-3756
Homepage URL
Email

Sponsor
Institute Saitama Medical Center,Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center,Saitama Medical University
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
2013 Year 05 Month 17 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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 18 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
2013 Year 05 Month 10 Day
Last modified on
2013 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012456

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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