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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006020
Receipt No. R000007125
Scientific Title Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Date of disclosure of the study information 2011/07/22
Last modified on 2019/01/26

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Basic information
Public title Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Acronym Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title:Acronym Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the efficacy and safety of EC followed by weekly Nab-paclitaxel as neoadjuvant chemotherapy for primary 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
Key secondary outcomes adverse event
clinical response rate
pathological response rate
rate of breast-conserving surgery
feasibility
overexpression rate of SPARC

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 weekly nab-paclitaxel

EC
Epi-ADM 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle

weekly nab-paclitaxel
nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-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 Histologically confirmed primary breast cancer

Clinical stage T1c-3 N0/M0 or T1-3 N1/M0

At least one measurable lesion

over 20 years old

No prior surgery, radiation, chemotherapy and endocrine therapy

Adequate baseline organ function (within 14 days before registration)
Hb--over 8.0 g/dL
WBC--over 3000 /mm3 and under 12,000 /mm3
Neu--over 2,000 / mm3
Plt--over 75,000 / mm3
T-Bil--under 3 times ULM
AST/ALT--under 3 times ULN
Cre--under ULN

ECOG performance status--0-2

written informed consent
Key exclusion criteria past medical history of drug allergy

HER2 positive breast cancer
(IHC 3+, IHC 2+ and FISH +)

Active double cancer

Severe complications

Symptomatic brain metastasis

Severe mental disorder

History of blood transfusions within 2 weeks

Sever bone marrow suppression, renal dysfunction, liver dysfunction

Body cavity fluid

watery diarrhea on registration

Active infection or potentiality infection

allergic reaction of the nab-paclitaxel, paclitaxel or albumin


During pregnancy or lactation

Judged by the investigator to be unfit to be enrolled into the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address 143 Shimokasuya, Isehara-shi, Kanagawa, Japan 259-1193
TEL +81-463-93-1121
Email luke-szk@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Suzuki
Organization Tokai University School of Medicine
Division name Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address 143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL +81-463-93-1121
Homepage URL
Email luke-szk@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
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
2011 Year 07 Month 22 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
2011 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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
2011 Year 07 Month 22 Day
Last modified on
2019 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007125

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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