UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011258
Receipt number R000013166
Scientific Title Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer
Date of disclosure of the study information 2013/09/01
Last modified on 2013/07/22 16:13:50

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Basic information

Public title

Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer

Acronym

KBCOG13

Scientific Title

Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer

Scientific Title:Acronym

KBCOG13

Region

Japan


Condition

Condition

brest cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of S-1(administered day1-14,followed by 7days rest) for metastatic or recurrence breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival
Time to Treatment failure
Response rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 depending on BSA and Ccr is administered orally twice daily after morning and evening meals from day1-14,followed by 7 days rest

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

Male and Female

Key inclusion criteria

1)histologically comfirmed breast cancer
2)metastatic or recurrent breast cancer
3)with at least one evaluable lesion
4)without chemotherapy after decided metastatic or recurrent cancer
5)over 20 years old
6)EOG perfomance status 0-2
7)without previous 5-FU chemotherapy or with interval period of 6months after pre or post operative 5-FU chemothrapy
8)with interval period of 7days after endocrine therapy,or with interval period of 14days after radiation therapy
9)required baseline laboratory parameters
WBC>3000/mm3
neutrophili>1500/mm3
Plt>100,000/mm3
T-Bil<2.0mg/dL
AST,ALT<100IU/L
Ccr>50mL/min
10)without severe heart problem
11)written informed consent was obtained

Key exclusion criteria

1)HER2 positive
2)allergy for the medicine of the protocol
3)active double cancer
4)brain metastasis which needs treatment or radiation therapy in an emergency
5)severe liver metastasis or Lung metastasis with dyspnea
6)with pleural effusion,ascitis,ericardial effusion which needs treatment in an emergency
7)active infection
8)interstitial pneumonia
9)HBV antigen positive
10)uncontoroled diabetes mellitus
11)mental disease
12)pregnant or nursing women ,women who like to be
pregnant
13)with doctors decision for exclusion

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mayuko Miki

Organization

Hyogo Cancer Center

Division name

Breast Surgical Oncology

Zip code


Address

13-70,Kitaoujityou,Akashi-city,Hyogo,Japan,6728558

TEL

0789291151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Mayuko Miki

Organization

Hyogo Cancet Center

Division name

Breast Surgical Oncology

Zip code


Address

13-70,Kitaoujityou,Akashi-city,Hyogo,Japan,6728558

TEL

0789291151

Homepage URL


Email

mikimayu@hyogo-cc.jp


Sponsor or person

Institute

Kobe Breast Cancer Oncology Group

Institute

Department

Personal name



Funding Source

Organization

KBCOG

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

兵庫県立がんセンター(兵庫県)、甲南病院(兵庫県)、兵庫県立西宮病院(兵庫県)、兵庫県立加古川医療センター(兵庫県)、茶屋町ブレストクリニック(大阪府)、淀川キリスト教病院(大阪府)、大阪府済生会中津病院(大阪府)、こくふブレストクリニック(兵庫県)、神戸大学医学部付属病院(兵庫県)、西神戸医療センター(兵庫県)、いしづか乳腺クリニック(兵庫県)、製鉄記念広畑病院(兵庫県)、甲南加古川病院(兵庫県)、兵庫医科大学(兵庫県)、済生会兵庫県病院(兵庫県)、明石医療センター(兵庫県)、明和病院(兵庫県)、姫路赤十字病院(兵庫県)、愛仁会高槻病院(大阪府)、神鋼病院(兵庫県)、橋本クリニック(兵庫県)、兵庫県立塚口病院(兵庫県)、大山病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 Day


Related information

URL releasing protocol


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

Open public recruiting

Date of protocol fixation

2013 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2018 Year 09 Month 01 Day

Date of closure to data entry

2018 Year 10 Month 01 Day

Date trial data considered complete

2018 Year 10 Month 01 Day

Date analysis concluded

2018 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 23 Day

Last modified on

2013 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name