UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000011
Receipt number R000000020
Scientific Title Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer
Date of disclosure of the study information 2005/06/22
Last modified on 2019/11/21 15:58:03

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Basic information

Public title

Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer

Acronym

JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast cancer)

Scientific Title

Study of cyclophosphamide, epirubicin and fluoraouracil followed by docetaxel (CEF-DOC) as preoperative chemotherapy in primary operable breast cancer

Scientific Title:Acronym

JBCRG-01
(Study of CEF-DOC as primary systemic chemotherapy for operable berast cancer)

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

The purpose of this study is to evaluate the feasibility and safety as well as clinical and pathological response of cyclophosphamide, epirubicin and fluorouracil (CEF) followed by docetaxel (DOC) as primary systemic chemotherapyin patients with operable breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Clinicl response, pathologic response, safety

Key secondary outcomes

Breast-conserving rate, overall survival, 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 Maneuver

Interventions/Control_1

Primary systemic chemotherapy (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and fluorouracil 500 mg/m2, q3w x 4 cycles, followed by docetaxel 75 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

65 years-old >=

Gender

Female

Key inclusion criteria

Histologically-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 drug
Serious coexisting illness
Active double cancer
Bilateral breast cancer
Male breast cancer
Pregnant or postpartum women

Target sample size

200


Research contact person

Name of lead principal investigator

1st name 1)Masakazu 2)Yuichi
Middle name
Last name 1)Toi 2)Takatsuka

Organization

1)Graduate School of Medicine Kyoto University 2)Kansai Rosai Hospital

Division name

1)Department of Surgery (Breast Surgery) 2)Department of Breast Surgery

Zip code

606-8507

Address

54 Kawara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan

TEL

075-751-3660

Email

toi@kuhp.kyoto-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 Research Group (JBCRG)

Institute

Department

Personal name



Funding Source

Organization

Osaka Cancer Research Foundation, Advanced Clinical Research Organization

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

JBCRG

Address

9-4-3F, 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

2005 Year 06 Month 22 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

Totally 202 patients were enrolled, and final clinical resposne, safety and pCR data were published (Breast Cancer Res Treat. 2007).

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

2002 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2002 Year 06 Month 01 Day

Last follow-up date

2007 Year 01 Month 01 Day

Date of closure to data entry

2007 Year 01 Month 01 Day

Date trial data considered complete

2007 Year 01 Month 01 Day

Date analysis concluded

2007 Year 03 Month 01 Day


Other

Other related information

Presentation: The 11th Annual Meeting of Jpn Breast Cancer Soc (2003), The 41st Annual Meeting of Jpn Soc for Cancer Ther (2003), The 15th ICACT(2004), The 12th Annual Meeting of Jpn Breast Cancer Soc (2004), The 1st Annual Meeting of OOTR (2004), The 27th SABCS(2004), The 13th Annual Meeting of Jpn Breast Cancer Soc (2005),5th EBCC(2006), 3rd OOT(2006)
Papers:Breast Cancer (12:99-103, 2005)


Management information

Registered date

2005 Year 06 Month 14 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=R000000020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name