UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000320
Receipt number R000000410
Scientific Title Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')
Date of disclosure of the study information 2006/02/02
Last modified on 2019/11/21 15:57:28

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Basic information

Public title

Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')

Acronym

Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')

Scientific Title

Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')

Scientific Title:Acronym

Validation study of FEC followed by docetaxel as preoperative chemotherapy in primary beast cancer (JBCRG-02')

Region

Japan


Condition

Condition

Primary breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

validation of efficacy and safety of JBCRG-02

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Safety, clinical and pathological response

Key secondary outcomes

Breast-conserving rate, 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

Primary systemic chemotherapy: fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2, q3w x 4 cycles + Docetaxel 100 mg/m2, q3w 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

60 years-old >

Gender

Female

Key inclusion criteria

Histologiccally-proven breast cancer
T1c-3N0M0/T1-3N1M0
No prior therapy for breast cancer
Performance status 0-1
Adequate hematologic, renal, hepatic and cardiac function
Written informed consent

Key exclusion criteria

Hypersensitivity for drugs
Serious coexisting illness
Active double cancer
Bilateral breast cancer
Male breast cancer
Pregnant or postpartum wemen

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Seigo
Middle name
Last name Nakamura

Organization

St Luke's International Hospital

Division name

Breast Center

Zip code

104-8560

Address

9-1 Akashi, Chuo-ku, Tokyo

TEL

03-3541-5151

Email

seigonak@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Katsumasa
Middle name
Last name Kuroi

Organization

JBCRG

Division name

Head office

Zip code

103-0016

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan

TEL

03-6264-8873

Homepage URL

https://jbcrg.jp/

Email

office@jbcrg.jp


Sponsor or person

Institute

Japan Breast Cancer Reaserch Group (JBCRG)

Institute

Department

Personal name



Funding Source

Organization

Advanced Clinical Reaserch Organization (ACRO)

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

JBCRG

Address

9-4 Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan

Tel

03-6264-8873

Email

office@jbcrg.jp


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

2006 Year 02 Month 02 Day


Related information

URL releasing protocol


Publication of results

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

2005 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 12 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 06 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2012 Year 01 Month 01 Day


Other

Other related information

Presentation:14th&15th Annual meeting of Japanese Breast Cancer Society(2006&2007),
2nd OOTR(2005), 29th SABCS(2006)
Paper: Biomed Pharmacother(2005, Oct;59 Suppl 2:S387-92), BIG News Letter(2006, 8(1)), Breast Cacer(2006, 13(1) p38-48), JJBC(2007,23(2), p111-117)


Management information

Registered date

2006 Year 02 Month 02 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000410


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name