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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004340
Receipt No. R000005164
Scientific Title Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy
Date of disclosure of the study information 2010/10/06
Last modified on 2018/10/12

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Basic information
Public title Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy
Acronym Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy(KBCSG01)
Scientific Title Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy
Scientific Title:Acronym Phase II trial of S-1 monotherapy as adjuvant chemotherapy in triple negative breast cancer patients who did not achieve pathological complete response after neoadjuvant chemotherapy(KBCSG01)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of S-1 as adjuvant chemotherapy in triple negative breast cancer patients which did not achieve non-pCR after neoadjuvant chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes feasibility, safety
Key secondary outcomes disease free survival, overall survival, drug compliance

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 is administered orally at 80 mg/m2 for 28 consecutive days followed by a 14 days rest. Cycles are repeated every 6 weeks until 4 courses.
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)Pathologically proven primary female breast cancer
2)stage I-IIIA patients who underwent curative operation
3)Patients with histologically diagnosed residual invasive cancer after preoperative chemotherapy
4)HER2 negative
5)low expression of ER and PgR
6)age: >=20 and <=70
7)Performance Status: 0-1(ECOG)
8)No-carry-over effect of prior treatment
9)sufficient function of important organs
a)WBC: >=3,000/mm3
b)Neutrophyl: >=1,500/mm3
c)Platelet: >=100,000/mm3
d)Hemoglobin: >=9g/dl
e)GOT, GPT: <= 2.5 times of the upper limit of normal range in each institute
f)ALP: <= 2.5 times of the upper limit of normal range in each institute
g)sT.bil: <= 2.5 times of the upper limit of normal range in each institute
h)Ccr: >=60 ml/min/body
10)written informed consent
11)with ability of oral intake
Key exclusion criteria 1)patients receiving oral 5-FU based chemotherapy
2)with active double cancer
3)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis)
4) pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant
5)with history of mental disorder or treating it at the moment
6)with history of severe allergy
7)with severe allergy to 5-FU based drug
8)patients receiving 5-FU based chemotherapy
9)patients receiving Flucytosine
10)Bilateral breast cancer, either simultaneous or metachronal
11)inflammatory breast cancer
12)Impossible to take oral drugs
13)doctor's decision not to be registered to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Watanabe
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL 0427788111
Email y-kosaka@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Kosaka
Organization Kitasato University School of Medicine
Division name Department of Surgery
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL 0427788111
Homepage URL
Email y-kosaka@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine
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 北里大学病院(神奈川県)、北里大学北里研究所 メディカルセンター病院(埼玉県)、上尾中央総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 06 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 Completed
Date of protocol fixation
2010 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2019 Year 02 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
2010 Year 10 Month 06 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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