UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005219
Receipt number R000006190
Scientific Title Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes
Date of disclosure of the study information 2011/03/08
Last modified on 2018/09/18 15:50:48

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Basic information

Public title

Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes

Acronym

WJOG6110B: Early switch to Lapatinib versus Trastuzumab beyond Progression (ELTOP) study

Scientific Title

Randomized phase II trial evaluating trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes

Scientific Title:Acronym

WJOG6110B: Early switch to Lapatinib versus Trastuzumab beyond Progression (ELTOP) study

Region

Japan


Condition

Condition

HER2-positive metastatic breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluating efficacy and safety of trastuzumab + capecitabine (HX) or lapatinib + capecitabine (LX) in HER2-positive metastatic breast cancer patients previously treated with trastuzumab and taxanes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall response rate, overall survival, proportion of subjects progressing with brain metastases as site of first progression, and safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

trastuzumab + capecitabine

Interventions/Control_2

lapatinib + capecitabine

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) Pathologically confirmed invasive breast cancer
2) ECOG performance status 0-2
3) Metastatic breast cancer or unresectable locally advanced (stage IIIB/IIIC) breast cancer
4) HER2 positive (3+ staining by immunohistochemistry [IHC] or HER2 gene amplification [HER2:CEP17 signal ratio of 2.0 or more] by FISH) confirmed in the invasive component of the primary or metastatic lesion
5) Previously treated with taxanes
6) Disease progression or distant relapse has been observed during treatment with trastuzumab-containing regimens.
7) Previously untreated with oral fluoropyrimidines including capecitabine and S-1 (Eligible if oral fluoropyrimidines other than capecitabine and S-1 are used only in neo-adjuvant or adjuvant setting)
8) Previously untreated with HER2 tyrosine kinase inhibitors
9) Previously treated with no more than two chemotherapy regimens for metastatic or unresectable locally advanced disease
10) No brain metastases or asymptomatic brain metastases
11) Subjects who have either measurable or non-measurable disease other than brain metastases
12) Able to swallow oral medications
13) Adequate baseline organ and marrow function as defined below:
Absolute neutrophil count >=1.5x10^9/L
Hemoglobin >=9.0 g/dL
Platelets >=100x10^9/L
AST and ALT <=100IU/L
Serum bilirubin <=1.5 mg/dL
Serum creatinine <=1.5 mg/dL
14) Baseline LVEF >= 50% by echocardiography
15) Life expectancy of at least 3 months
16) Signed written informed consent

Key exclusion criteria

1) History of other malignancy,except for curatively treated carcinoma in situ or intramucosal carcinoma (Subjects with other malignancies who have been disease-free for at least 5 years are eligible.)
2) Active infection under treatment
3) Concurrent serious disease or condition
4) Pulmonary fibrosis or interstitial pneumonitis by chest x-ray
5) Symptomatic brain metastases or carcinomatous meningitis
6) History of serious allergic reactions
7) Concurrent continuous systemic treatment with medications listed below:
Steroids
Warfarin
CYP3A4 inducing anticonvulsants
Rifampicin
Azole antifungals
8) Concurrent serious psychiatric disorder
9) Pregnant or lactating females or subjects of childbearing potential who do not agree to use adequate contraception
10) HBsAg-positive

Target sample size

110


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshimi Takano

Organization

Toranomon Hospital

Division name

Department of Medical Oncology

Zip code


Address

2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan

TEL

03-3588-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address

Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

GlaxoSmithKline K.K.

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 03 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29698927

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

2011 Year 02 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 08 Day

Last modified on

2018 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006190


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name