UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001414
Receipt number R000001719
Scientific Title Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).
Date of disclosure of the study information 2008/10/06
Last modified on 2017/11/30 18:04:15

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Basic information

Public title

Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).

Acronym

Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).

Scientific Title

Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).

Scientific Title:Acronym

Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).

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

Evaluate the feasibility, safety and efficacy of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy and radiotherapy that was carried out if necessary, for ER negative, PgR negative and HER2 negative breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility

Key secondary outcomes

Safety
Overall survial
Disease free survival
Relative dose intensity
Biomarkers


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

S-1 80mg/m2 b.i.d., day1-14 q3w, 1 yr

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

70 years-old >=

Gender

Female

Key inclusion criteria

1) Histologically confirmed primary breast cancer.
2) ER(-), PgR(-) and HER2(-)
3) Received primary systemic therapy.
4) Age more than 20years and less than 75 years.
5) ECOG performance status of 0 or 1.
6) Possible to take orally
7) Required baseline laboratory parameters (within 14 days before registration):
WBC more than 4000 /mm3
Neu more than 2000 / mm3
Plt more than 100,000/mm3
Hb more than 9.0g/dl
AST less than 2.5 times ULN
ALT less than 2.5 times ULN
T-Bil less than 1.5mg/dl
Cre less than 1.2mg/dl
Ccr more than 60ml/min
8) Signed informed consent of the patient for the registration.

Key exclusion criteria

1) Either of ER, PgR, HER2 is positive by surgical specimen.
2) Male breast cancer
3) Severe complications (uncontrolled diabetes mellitus, infection, heart failure which needs medical treatment (unstable angina pectoris, history of myocardial infarction occurred within 6 months), mental disorder)
4) Interstitial lung disease, pulmonary fibrosis
5) History of serious drug allergy
6) Active other malignancies
7) During pregnancy or lactation
8) History of hypersensitivity
9) History of serious hypersensitivity to fluoropyrimidines
10) During administration of fluoropyrimidines
11) During administration of flucytosine
12) Patients judged inappropriate by physicians

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Tabei

Organization

Saitama Cancer Center

Division name

Breast Medical Oncology

Zip code


Address

818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihiro Kai

Organization

Saitama Breast Cancer Clinical Study Group(SBCCSG)

Division name

Secretariat Division (Shintoshin Ladies' MammoClinic)

Zip code


Address

3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org


Sponsor or person

Institute

Saitama Breast Cancer Clinical Study Group(SBCCSG)

Institute

Department

Personal name



Funding Source

Organization

None

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



Other administrative information

Date of disclosure of the study information

2008 Year 10 Month 06 Day


Related information

URL releasing protocol


Publication of results

Partially 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

No longer recruiting

Date of protocol fixation

2008 Year 06 Month 18 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2015 Year 10 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

2008 Year 10 Month 05 Day

Last modified on

2017 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001719


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name