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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010579
Receipt No. R000012338
Scientific Title Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Date of disclosure of the study information 2013/04/30
Last modified on 2013/04/21

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Basic information
Public title Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Acronym Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Scientific Title Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Scientific Title:Acronym Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.
Region
Japan

Condition
Condition HER2 positive 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 and trastuzumab followed by FEC as neoadjuvant chemotherapy for primary breast cancer.
Basic objectives2 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
Histological effect
Breast preserving operation rate
Frequency of side effects

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 and trastuzumab followed by 4 cycles of FEC.
Nab-paclitaxel(nab-paclitaxel: 260mg/m2, iv, day 1 every 3 weeks)
Trastuzumab*(6mg/kg, iv, day1 every 3 weeks)
*:4 mg/kg for the initial dosing(day1)
every 3 weeks x 4 cycles.
FEC (Epirubicin 100 mg/m2 and CPA 500 mg/m2 and 5-FU 500mg/m2 iv,day 1)
every 3 weeks x 4 cycles.
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
75 years-old >=
Gender Female
Key inclusion criteria 1) Histological confirmed invasive breast cancer
2) Clinical stage T1-3, N1-3, M0
3) With evaluable tumor lesions
4) HER2 positive (IHC 3+ or IHC2+, FISH +)
5) Age 20 to 75
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) ECOG performance status 0 - 1
8) preserving the functions of bone marrow, heart, liver, and kidney
granulocyte count 1,500 / mm3 or more
Platelet 100,000/mm3 or more
Hb 9.0g/dl or more
AST(GOT) less than 2.5-times the upper limit of normal
ALT(GPT) less than 2.5-times the upper limit of normal
Total-bilirubin 1.5 mg/dL or less
serum creatinine 1.5 mg/dL or less
9) Signed informed consent of the patient for the registration.
Key exclusion criteria 1) Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil
2) Active secondary malignancies
3) Bilateral invasive breast cancer
4) Severe complications (infection, diarrhea, paresis of intestine, obstruction of the intestines, uncontrolled diabetes mellitus, etc.)
5) Positive for HBs antigen and the history of HBV infection
6) Severe heart disease, or the patient who has past history of it
7) Severe mental disease or under treatment
8) Active gastrointestinal tract ulcer or bleeding
9) Severe bone marrow suppression, renal dysfunction, and liver dysfunction
10) Severe pleural effusion or ascites
12) Pregnancy or suspected pregnancy
13) Physician judged improper to entry this trial
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Inokuchi
Organization Kanazawa University Hospital
Division name Department of Breast Oncology
Zip code
Address 13-1 Takara-machi, Kanazawa city, Ishikawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University
Division name Department of gastroenterologic and breast surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of gastroenterologic and breast surgery
Kanazawa University,School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 04 Month 30 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 07 Month 26 Day
Date of IRB
Anticipated trial start date
2012 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
2013 Year 04 Month 24 Day
Last modified on
2013 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012338

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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