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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007153
Receipt No. R000008404
Scientific Title Investigation of correlation between antitumor effect of combined lapatinib/capecitabine therapy and p95HER2, PTEN and PIK3CA in patients with HER2 positive breast cancer
Date of disclosure of the study information 2012/01/28
Last modified on 2018/05/14

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Basic information
Public title Investigation of correlation between antitumor effect of combined lapatinib/capecitabine therapy and p95HER2, PTEN and PIK3CA in patients with HER2 positive breast cancer

Acronym Lapatinib biomarker study(KBC-SG 1107)
Scientific Title Investigation of correlation between antitumor effect of combined lapatinib/capecitabine therapy and p95HER2, PTEN and PIK3CA in patients with HER2 positive breast cancer

Scientific Title:Acronym Lapatinib biomarker study(KBC-SG 1107)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Endocrine surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate correlation between biological markers (p95 HER2, PTEN expression and PIK3CA gene mutation) and a progression-free survival (PFS) of HER2-positive breast cancer patients who received lapatinib and capecitabine combination therapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Correlation between PFS and expression levels of p95HER2 and PTEN protein and PIK3CA gene mutation.
Key secondary outcomes Correlation between above 3 biological markers and following clinical indicators, i.e. tumor regression, clinical benefit, overall survival and adverse events

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 capecitabine:10mg/m2 po, bid for 14days followed by 1 week off
lapatinib: 1250mg/body po, dayly
both drugs continue until the disease progress or adverse events become intolerable
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.Women with a histopathological diagnosis of invasive breast carcinoma
2.Inoperable or recurrent breast cancer
3.HER2 positive breast cancer
4.Previous treatment with anthracyclines and trasuzumab
5.no previous treatment with capecitabine
6.patients who received less than 2 regimen of chemotherapy
7.Previously untreated with HER2 inhibitor other than trasuzumab (lapatinib is included)
8.Having measurable lesions
9.The tumor preserved can be offered for biomarker studies
10.Aged 20 or over
11.Performance Status(ECOG scale):0-1
12.Off-therapy period prior to the study: >=14 days
13.Adequate organ functions confirmed by blood tests taken conducted within 14 days before registration
leukocyte>=3000mm3 or neutrophil>=1500mm3
hemoglobin>=9.0g/dL
platelet count>=100,000/mm3
AST,ALT<=more than 3 times ULN
total bilirubin=< more than 1.5 times ULN
serum creatinine<=1.5mg/dL
ejection fraction=>50%
14.Oral intake is possible
15.Written informed consent

Key exclusion criteria 1.Pregnant or lactation women, or women with suspected pregnancy
2.Patients who suffer malabsorption syndrome or disease affecting gastro intestinal function, or resection or stomach or small intestine, or ulcerative colitis
3.Coexistence malignant tumor other than breast cancer or a history of such tumor within 5 years of the beginning of this study
4.Patients who has not recovered from previous cancer treatment to less than G1 toxicity
5.Previous or current history of interstitial pneumonia
6.Active or poorly controlled infectious diseases
7.Severe psychiatric disorder
8.Poorly controlled or symptomatic angina pectoris, arrhythmia or congestive heart failure
9.Symptomatic CNS metastasis
10.Meningitis carcinomatosa
11.History of immediate or delayed hypersensitivity reaction to the compounds similar to both capecitabine and lapatinib
12.Patients judged by the investigator to be unfit for the study
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Reiki Nishimura
Organization Kumamot City Hospital
Division name Breast & Endocrine Surgery
Zip code
Address 1-1-60, Koto, Kumamoto
TEL 096-365-1711
Email j_nishimura2002@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kazuo Tamura
Organization Kyushu Breast Cancer Study Group
Division name Exective office
Zip code
Address 1-8-17-204, watanabe-dori, Chuo-ku, Fukuoka
TEL 092-406-4166
Homepage URL
Email kbcsg@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization GlaxoSmithKline K.K.
Non-profit Organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 那覇西クリニック(沖縄県)、博愛会相良病院(鹿児島県)、熊本市民病院(熊本県)、うえお乳腺外科(大分県)、佐賀県立病院好生館(佐賀県)、久留米第一病院、福岡大学病院、島田乳腺・外科クリニック、久留米大学病院、北九州市立医療センター、九州がんセンター(福岡県)、広島市立安佐市民病院(広島県)、伊勢崎市民病院、横浜市立大学附属市民総合医療センター(神奈川県)、さいたま赤十字病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2012 Year 01 Month 27 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008404

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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