UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000265
Receipt number 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 22:43:40

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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 or person

Institute

Breast Cancer PST Study Group

Institute

Department

Personal name



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

Value
https://center6.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