UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002456
Receipt number R000003008
Scientific Title Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.
Date of disclosure of the study information 2009/09/07
Last modified on 2017/11/30 18:04:58

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Basic information

Public title

Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.

Acronym

Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.

Scientific Title

Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.

Scientific Title:Acronym

Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology Endocrine surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Phase II study of lapatinib plus capecitabin for the HER2 overexpressing metastatic breast cancer patients pretreated with oral-FU agents.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Clinical benefit rate

Key secondary outcomes

Safety
Overall response rate
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

Lapatinib at a dose of 1250 mg daily.
Capecitabine at a dose of 2000 mg per square meter of body-surface area in two divided doses on days 1 through 14 of a 21-day cycle.

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) Diagnosed HER2 over expression (IHC score 3+ or FISH positive) in primary or metastatic site
3) Patients who received previous treatment with oral FU agents
4) 6 months apart from the previous trastuzumab administration in adjuvant or neoadjuvant
5) Case who passes from the final administering of FU agents one month when FU agents is dministered by pre-treatment
6) Case to whom metastasis to central nervous system is steady
7) ECOG PS 0 to 2
8) Possible to take orally
9) Required baseline laboratory parameters within 14 days before it registers
AST <= 3.0 times ULN and ALT <= 3.0 times ULN
Case where abnormal shadow is not admitted by chest image inspection (X rays of chest or CT)
LVEF<=ULN(LVEF more than 50%)
Ccr >= 50ml/min (Cockcroft-Gault model)
Neu >= 1,500 / mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
10) Age>=20
11) Written informed consent

Key exclusion criteria

1) Concomitant infectious disease
2) History of lung disease, pulmonary fibrosis
3) Uncontrollable complication heart disease
4) have hypersensitivity to lapatinib and capecitabine
5) During pregnancy or lactation
6) History of serious hypersensitivity to fluoropyrimidines
7) Patients who received previous treatment with oral fluoropyrimidines within 12 months
8)The patient who has the risk of the extension at QT intervals is a case who assumes that it consults the specialist, and the treatment of the examination is inapposite.
9) Present case to whom radiation therapy is enforced
10) Doctors decision for excluion

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Inoue

Organization

Saitama Cancer Center

Division name

Breast Medical Oncology

Zip code


Address

818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihiro Kai

Organization

Saitama Breast Cancer Clinical Study Group(SBCCSG)

Division name

Secretariat Division (Shintoshin Ladies' MammoClinic)

Zip code


Address

3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org


Sponsor or person

Institute

Saitama Breast Cancer Clinical Study Group(SBCCSG)

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

2009 Year 09 Month 07 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

2009 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2016 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

2009 Year 09 Month 06 Day

Last modified on

2017 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003008


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name