UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004340 |
|---|---|
| Receipt number | 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 22:35:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
y-kosaka@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005164
