UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Toshimi Takano
Organization	Toranomon Hospital
Division name	Department of Medical Oncology
Address	2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL	03-3588-1111
Email

Public contact
Name of contact person	Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
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
Institute	West Japan Oncology Group
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29698927
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006190