UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011049
Receipt number R000012932
Scientific Title Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Date of disclosure of the study information 2013/06/26
Last modified on 2019/02/04 18:15:22

* 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

Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Acronym

Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Scientific Title

Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Scientific Title:Acronym

Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to assess the safety of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

adverse event

Key secondary outcomes

response rate, progression free survival


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 twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest.
Trastuzumab 6 mg/kg* administered intravenously on day 1 of each 3-week cycle
*:8 mg/kg for the initial dosing

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


Not applicable

Gender

Female

Key inclusion criteria

1) Histological and/or cytological confirmed breast cancer
2) HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods
3) ECOG performance status 0-2
4) Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan)
5) Age 20 or over
6) Adequate function of important organs (within 14 days before registaration)
1. WBC: >=4,000/mm3
2. Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T-Bil <= 1.5mg/dL
6. AST <= ULN x 2.5
7. ALT <= ULN x 2.5
8. Creatinin <= 1.5mg/dL
9.Ccr: >=60mL/min
7) Expected survival time: more than 6 months
8) Written informed consent

Key exclusion criteria

1) History of hypersensitivity reaction
2) Sever bone marrow suppression, renal dysfunction, liver dysfunction
3) Received S-1
4) Inflammatory breast cancer
5) Active double cancer
6) With widespread liver metastases or with dyspnea in pulmonary lymphangitis
7) With brain metastasis
8) With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease
9) Insulin therapy or Uncontrolled diabetes
10) With pulmonary fibrosis or pneumonitis
11) With dyspnea at rest
12) With pleural effusion, ascites, pericardial effusion
13) Active infection or potentiality infection
14) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
15) Judged ineligible based on physicians' decision

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Seki

Organization

Kitasato University Kitasato Institute Hospital

Division name

Breast Center

Zip code


Address

Shirokane5-9-1 Minato-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kitasato University Kitasato Institute Hospital

Division name

Breast Center

Zip code


Address

Shirokane5-9-1 Minato-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Kitasato University Kitasato Institute Hospital

Institute

Department

Personal name



Funding Source

Organization

Kitasato University Kitasato Institute Hospital

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



Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 26 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

Terminated

Date of protocol fixation

2013 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 21 Day

Last follow-up date


Date of closure to data entry

2019 Year 02 Month 04 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 26 Day

Last modified on

2019 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name