UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Title of the study (Brief title)	A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Progression-free survival Overall survival Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Pertuzumab:840mg/body intravenously administred on day 1 every 3 weeks (loading dose:840mg/body) Trastuzumab:6mg/kg intravenously administred on day 1 every 3 weeks (loading dose:8mg/kg) Capecitabine:2,000 mg/m2/day orally in 2 divided doses for 2 weeks followed by 1week rest
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	1) Histologically confirmed breast cancer. 2) HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH) metastatic breast cancer. 3) Patients with at least one or more prior chemotherapy combined trastuzumab. 4) No prior treatment by capecitabine for present primary breast cancer. 5) Patients with measurable lesion. 6) Left ventricle ejection fraction 50% or over by cardiac sonography within 28 days prior to entry. 7) Age between 20 and 70 years. 8) ECOG performance status 0 to 2. 9) Expected survival longer than 3 months. 10) Sufficient functions of important organs WBC>=3,000/mm3 Neurtophils>=1,500/mm3 Platelets>=80,000/mm3 Hemoglobin>=9.0g/dl AST<=2.0 X ULN ALT<=2.0 X ULN Total bilirubin<=2.0mg/dl Creatinine<=2.0mg/dl 11) All of HBs antigen, HBs antibody, HBc antibody and HCV antibody are negative. 12) Written informed consent to participate.
Key exclusion criteria	1) History of hypersensitivity reaction 2) Brain metastasis 3) Pleural effusion, ascites, and pericardial fluid requiring treatment 4) Active another cancer 5) Active infection 6) Other severe complications, such as heart failure, interstitial pneumonia and renal failure with clinically problem 7) Required treatment with steroid 8) Pregnant or possibility pregnancy or nursing women 9) Mental disorder which become problem on clinical practice 10) Physician judged improper to entry this trial
Target sample size	24

Research contact person
Name of lead principal investigator	Keisuke Miwa
Organization	Kurume University Hospital
Division name	Cancer Multidisciplinary Treatment Center
Address	67 Asahi-machi, Kurume city, Fukuoka
TEL	0942-35-3311
Email	miwakeisuke@gmail.com

Public contact
Name of contact person	Keisuke Miwa
Organization	Kurume University Hospital
Division name	Cancer Multidisciplinary Treatment Center
Address	67 Asahi-machi, Kurume city, Fukuoka
TEL	0942-35-3311
Homepage URL
Email	miwakeisuke@gmail.com

Sponsor
Institute	Kurume University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	久留米大学病院(福岡県)、社会保険久留米第一病院(福岡県)、国立病院機構九州医療センター(福岡県)、公立八女総合病院企業団(福岡県)、大牟田市立総合病院(福岡県)、聖マリア病院(福岡県)、大分県済生会日田病院(大分県)

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 21 Day
Anticipated trial start date	2013 Year 11 Month 05 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 04 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014275