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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009853
Receipt No. R000011543
Scientific Title Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Date of disclosure of the study information 2013/02/01
Last modified on 2016/08/09

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Basic information
Public title Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Acronym EC followed by ABI neoadjuvant chemotherapy for node positive breast cancer (Phase II Trial)
Scientific Title Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Scientific Title:Acronym EC followed by ABI neoadjuvant chemotherapy for node positive breast cancer (Phase II Trial)
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 Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes Secondary endpoint is to evaluate the Clinical response rate, pathological 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 EC(Epi-ADM 90mg/m2 and Cyclophosphamide 600mg/m2) is administered. One course is consisted by 3 weeks and repeated to 4 courses.
After administrated 4 courses of EC, ABI 260mg/m2 is administered. One course is consisted by 3 weeks and repeated to 4 courses.
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 breast cancer confirmed by needle biopsy.
2) Clinical stage T1-3, >=N1, M0
3) expected to radical cure by operation and neoadjuvant chemotherapy
4) has measurable region
5) Age 20 to 70
6) No prior surgery, radiation, chemotherapy and endcrinethrapy
7) Required baseline laboratory parameters (within 2 weeks before registration):
Hb more than 9.0g/dl
WBC more than 4000 /mm3
Neu more than 2000 / mm3
Plt more than 100,000/mm3
T-Bil less than 1.5 mg/dL
AST(GOT) less than 2.5-times the upper limit of normal
ALT(GPT) less than 2.5-times the upper limit of normal
Cre less than 1.5 mg/dL
cardiac electrogram : No clinically important abnormal finding
8)ECOG performance status is 0 to 1
9)Signed informed consent of the patient for the registration by their own volition.
Key exclusion criteria 1) History of sever hypersensitivity
2) Active other malignancies
3) Severe complications (infection, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure etc.)
4) has psychological illness which became a problem in practice
5) sever bone suppression, renal dysfunction, and liver dysfunction
6) sever pleural effusion or ascites fluid
7) has infection or fever which suspected of infection
8) pregnant or possibility of pregnant
9) Patients judged inappropriate by physicians
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kato
Organization Dokkyo Medical University
Division name Surgery 1
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2157
Email hkato@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Ito
Organization Dokkyo Medical University
Division name Surgery 1
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2157
Homepage URL
Email j-ito@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 02 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 Completed
Date of protocol fixation
2011 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 23 Day
Last modified on
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011543

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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