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

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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 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


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

Value
https://center6.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