UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001408
Receipt number R000001640
Scientific Title A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer
Date of disclosure of the study information 2008/10/01
Last modified on 2013/10/04 09:19:33

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Basic information

Public title

A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer

Acronym

A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer

Scientific Title

A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer

Scientific Title:Acronym

A Phase II Study of Trastuzumab plus S-1 in Patients with Advanced or Recurrent HER2 positive Breast Cancer

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Endocrine surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of trastuzumab in combination with S-1 in patients with advanced/recurrent breast cancer with HER2 positive disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response Rate

Key secondary outcomes

Safety
Overall survial
Progression free survival
Time to treatment failure
Biomarkers


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 80mg/m2 twice daily on days1-14 every 3 weeks.

Trastuzumab 6mg/kg (First time 8mg/kg) i.v., every 3 weeks

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

80 years-old >=

Gender

Female

Key inclusion criteria

1) Histologically diagnosed breast cancer
2) Advanced or recurrence breast cancer with measurable lesions
3) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site
4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant
5) No prior radiotherapy
6) Age 20 to 80 years
7) ECOG PS 0 to 2
8) Expected survival time: more than 3 months
9) LVEF more than 55%
10) Required baseline laboratory parameters
WBC >= 3,500 /mm3 (or Neu >= 1,500 / mm3 ) and <= 12,000mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
AST <= 2.5 times ULN and ALT <= 2.5 times ULN
T-Bil <= 1.5mg/dl
Cre <= 1.2mg/dl or Ccr >= 60ml/min (Cockcroft-Gault model)
11) Written informed consent
12) Possible to take orally

Key exclusion criteria

1) Male breast cancer
2) Necessary to continue treatment with warfarin potassium
3) Severe complications [ulcer which needs blood transfusion, uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, cerebral thrombosis, cerebral hemorrhage, subarachnoid hemorrhage, ischemia attack, encephalosis, stenocardia, myocardial infarction, uncontrolled congestive heart failure or arrhythmia, intestinal tract paralysis, ileus, neurodegeneration disease, hepatic insufficiency, cirrhosis, renal insufficiency]
4) Active double cancer
5) Inflammatory breast cancer or symptomatic brain metastasis
6) Patients who have only the lesion which caught the radiation exposure
7) Patients who received previous treatment with oral fluoropyrimidines within 12 months
8) internal use of flucytosyne
9) doctors decision for excluion

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Horiguchi

Organization

Gunma University Graduate School of Medicine

Division name

Thoracic Visceral Organ Surgery

Zip code


Address

3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Jun Horiguchi

Organization

Gunma Breast Clinical Conference Study Group(GBCCSG)

Division name

Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho

Zip code


Address

3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Gunma Breast Clinical Conference Study Group(GBCCSG)

Institute

Department

Personal name



Funding Source

Organization

None

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

2008 Year 10 Month 01 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

2008 Year 07 Month 23 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2013 Year 08 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

2008 Year 10 Month 01 Day

Last modified on

2013 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001640


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name