UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011860
Receipt number R000013864
Scientific Title Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Date of disclosure of the study information 2013/10/01
Last modified on 2015/08/18 14:14:30

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Basic information

Public title

Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Acronym

Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Scientific Title

Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Scientific Title:Acronym

Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Non-inferiority of TS-1 to UFT as adjuvant chemotherapy for breast cancer.
(Randomized phaseII trial)

Primary endpoint :
disease-free survival

Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Primary endpoint :
disease-free survival

Key secondary outcomes

Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

UFT

Interventions/Control_2

TS-1

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) Women with a histopathological diagnosis of invasive breast cancer
2) Curative surgery was performed for an initial diagnosis of stage I to IIIA or stage IIIB breast cancer
3) HER2-negative breast cancer
4) Moderate or high risk of recurrence
5) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, The case that follows the regimen that was established in protocol
6) If postoperative endocrine therapy was being received, The case that follows the regimen that was established in protocol
7) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment.
8) Within one year after surgery and within 6 months after the start of postoperative endocrine therapy
9) Age more than 20 years old , and signed informed consent of the patient for the registration.
10) ECOG performance status is 0 to 1
11) Oral intake is possible

Key exclusion criteria

1) Active double cancer
2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer
3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer
(Patients who received intravenous 5-fluorouracil can be enrolled.)
4) Serious diarrhea
5) Others, Serious complications
6) Pregnant women, nursing women, or women who want to become pregnant
7) Patients judged to be unsuitable for enrollment in the study by their physicians

Target sample size

380


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidemi Furusawa

Organization

Breastopia Namba Hospital

Division name

Breast Surgical oncology

Zip code


Address

2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan

TEL

0985-32-7177

Email

k.abe@breastopia.org


Public contact

Name of contact person

1st name
Middle name
Last name Katsunori abe

Organization

Breastopia Namba Hospital

Division name

Breast Surgical oncology

Zip code


Address

2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan

TEL

0985-32-7177

Homepage URL


Email

k.abe@breastopia.org


Sponsor or person

Institute

Breastopia Namba Hospital

Institute

Department

Personal name



Funding Source

Organization

Breastopia Namba Hospital

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

ブレストピアなんば病院(宮崎県)


Other administrative information

Date of disclosure of the study information

2013 Year 10 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

Terminated

Date of protocol fixation

2012 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 25 Day

Last modified on

2015 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name