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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000265
Receipt No. R000000327
Scientific Title Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study
Date of disclosure of the study information 2005/10/16
Last modified on 2013/04/16

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Basic information
Public title Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study
Acronym Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study(PST0402)
Scientific Title Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study
Scientific Title:Acronym Sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease-a phase 2 study(PST0402)
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of sequential chemotherapy with FEC(fluoraouracil, epirubicin and cyclophosphamide) and P+H(weekly Paclitaxel+Trastuzumab) as primary systemic therapy for operable breast cancer with HER2 positive disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes pathological complete rseponse rate
Key secondary outcomes clinical response, treatment compliance, breast-conserving rate, safety, overall survical, disease-free survival

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 chemotherapy:FEC(fluoraouracil, epirubicin and cyclophosphamide)followed by P+H(weekly Paclitaxel+Trastuzumab)
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria Histologically confirmed mastocarcinoma except for non-invasive carcinoma
T1-3N+M0/T2-3N-M0
HER2 positiveby fluorescence in situ hybridization(FISH) or showed 3+ or 2+ overexpression by immunohistochemistry
No prior therapy for breast cancer
No operation/Performance status 0 or 1
Adequate hematologic,renal,hepatic and cardiac function
Written informed consent
Key exclusion criteria severe complication
suspicious of infection
Hypersensitivity for polyoxyethylene castor oil (Cremophor EL) containing drugs
grade 3 or 4 peripheral neuropathy
Male breast cancer
Pregnant or lactating women
Doctor' s decision for exclusion
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikazu MASUDA
Organization Osaka National Hospital
Division name Surgery(Breast Oncology)
Zip code
Address 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL 06-6942-1331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu MASUDA
Organization Breast Cancer PST Study Group
Division name Executive Office
Zip code
Address 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL 06-6942-1331
Homepage URL
Email nmasuda@alpha.ocn.ne.jp

Sponsor
Institute Breast Cancer PST Study Group
Institute
Department

Funding Source
Organization Breast Cancer PST Study Group
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
2005 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2004 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 10 Month 16 Day
Last modified on
2013 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000327

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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