UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001736
Receipt number R000002019
Scientific Title Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Date of disclosure of the study information 2009/02/27
Last modified on 2018/05/14 16:51:23

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Basic information

Public title

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Acronym

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Scientific Title

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Scientific Title:Acronym

Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)

Region

Japan


Condition

Condition

Primary breast cancer

Classification by specialty

Medicine in general Surgery in general Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clinical & pathological response and safety profile of neoadjuvant chemotherapy consisting of sequential treatment with paclitaxel monotherapy followed by FEC regimen for patients with primary breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Safety
Clinical efficacy
Overall survival
Disease free survival
Breast-conserving rate


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

Paclitaxel 80mg/m2 every week for 12 cycles.
5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles.
Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy.

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


Not applicable

Gender

Female

Key inclusion criteria

1.Histologicaly-proven primary resectable breast cancer with a tumor size of >=1cm and clinical stage of <=IIIA
2. No history of chemotherapy
3. No history of surgery, radiotherapy, hormonal therapy against breast cancer
4. ECOG PS 0, 1
5. Sufficient organ function
6. Written informed consent

Key exclusion criteria

1. Severe medical conditions
2. Suspected infectious disease
3. Alergy to clemohol EL
4. Severe peripheral neuropathy
5. Pregnant or lactating women

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maki Tanaka

Organization

Kurume Daiichi Social Insurance Hospital

Division name

Surgery

Zip code


Address

21 Kushihara-Cho, Kurume

TEL

0942-33-1211

Email

maki@tanaka.name


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Tamura

Organization

Kyushu Breast Cancer Study Group

Division name

Executive office

Zip code


Address

1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka

TEL

092-406-4166

Homepage URL

http://www.chotsg.com

Email

npo@chotsg.com


Sponsor or person

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Non-profit Organization Clinical Hematology/Oncology Study Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2009 Year 02 Month 27 Day


Related information

URL releasing protocol

http://www.chotsg.com

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

Completed

Date of protocol fixation

2008 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2015 Year 08 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

2009 Year 02 Month 25 Day

Last modified on

2018 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name