UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003969
Receipt number R000004786
Scientific Title Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Date of disclosure of the study information 2011/04/01
Last modified on 2021/02/05 16:00:05

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Basic information

Public title

Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Acronym

Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Scientific Title

Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Scientific Title:Acronym

Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A randomized, controlled study to determine whether S-1 combined with standard postoperative endocrine therapy more effectively inhibits recurrence than standard postoperative endocrine therapy alone in patients with estrogen receptor (ER)-positive, HER2-negative primary breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Invasive Disease-free survival

Key secondary outcomes

Overall survival
Distant Disease-free survival
Disease-free survival
Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients in this group receive standard postoperative endocrine therapy for 5 years.

Interventions/Control_2

Patients in this group receive standard postoperative endocrine therapy for 5 years and oral S-1 for 1 year.

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

75 years-old >=

Gender

Female

Key inclusion criteria

1) Women with a histopathological diagnosis of invasive breast cancer
2) Curative surgery was performed for an initial diagnosis of stage I to IIIA or stage IIIB breast cancer
3) ER-positive breast cancer
4) HER2-negative breast cancer
5) Moderate or high risk of recurrence
6) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, the regimen(s) was/were conducted in accordance with the protocol.
7) If postoperative endocrine therapy was being received, the regimen was conducted in accordance with the protocol.
8) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment.
9) Within 1 year after surgery and within 6 months after the start of postoperative endocrine therapy
10) An age of 20 years to 75 years
11) A performance status (Eastern Oncology Cooperative Group) of 0 or 1
12) Oral intake is possible.
13) Main organ functions are preserved.
14) Written informed consent was obtained from the patient.

Key exclusion criteria

1) Active double cancer
2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer
3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer
(Patients who received intravenous 5-fluorouracil can be enrolled.)
4) Serious diarrhea
5) Serious complications
6) A history of myocardial infarction within the past 6 months, interstitial pneumonia, or allergy to fluoropyrimidine derivatives
7) Pregnant women, nursing women, or women who want to become pregnant
8) Patients judged to be unsuitable for enrollment in the study by their physicians

Target sample size

1860


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Toi

Organization

Graduate School of Medicine, Kyoto University

Division name

Breast Surgery

Zip code


Address

54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Email

toi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Takada

Organization

Graduate School of Medicine, Kyoto University

Division name

Breast Surgery

Zip code


Address

54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan

TEL

075-751-3660

Homepage URL


Email

masahiro@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Breast Surgery, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Taiho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

2011 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

1930

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

Main results already published

Date of protocol fixation

2010 Year 07 Month 06 Day

Date of IRB

2010 Year 09 Month 16 Day

Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2021 Year 01 Month 31 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 07 Month 30 Day

Last modified on

2021 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name