UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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(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	Masahiko Watanabe
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
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	Yoshimasa Kosaka
Organization	Kitasato University School of Medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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