UMIN-CTR Clinical Trial

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

Breast cancer

Classification by specialty

Hematology and clinical oncology	Surgery in general	Endocrine surgery
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

01

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2012

Year

01

Month

27

Day

Last modified on

2018

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008404