UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Title of the study (Brief title)	A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
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	To evaluate effectiveness and safty of pertuzumab+trastuzumab+capecitabine in patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival Overall survival Clinical benefit rate Time to treatment failure safety profiles

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+trastuzumab+capecitabine
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.Pathologically confirmed invasive breast cancer. 2.>=20years old 3.HER2 positive (3+staining by immunohistochemistry or HER2 geneamplification signal ratio of 2.0 or more by FISH or DISH) confirmed in the invasive component of the primary or metastatic lesion. 4.Patients with taxans (docetaxel/paclitaxel/Nab-paclitaxel) refractory and previously treatments reportable 5.Patients without previous irradiation for terget lesion,but exclude the new lesion from previous irradiation points. 6.ECOG PS 0-2 7.Baseline LVEF>=50% by echocardiography or MUGA 8.Adequate baseline organ and marrow fuction as defined below Absolute neutrophil count >=1500mm3 hemmoglobin >=9.0g/dl platelet count >=100000/mm3 AST/ALT 3 times of the facilities normal level total bilirubin=<1.5mg/dl serum creatinine=<1.5mg/dl (If patient with liver metastatic,5 times of the facilities normal leve to be able to enrolled ) 9.Creatinine clearance>50mL/min.
Key exclusion criteria	1.Patients received capecitabine,pertuzumab. 2.Have hypersensitivity to Trastuzumab. 3.History of allergic reactions for capecitabine or fluoropyrimidines. 4.Patient during the therapy enforcement of immunity or hormon therapy. 5..During pregnancy or lactation. 6.Symptomatic brain metastasis. 7.With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease. 8.Pulmonary fibrosis or pneumonia. 9.Dyspnea at rest. 10.With pleural effusion, ascites, pericardial effusion. 11Active infection or potentiality infection. 12.Serious drug allergy. 13.Active double cancer. 14.Only bone metastasis. 15.Judged by the investigator to be unfit to be enrolled into the study.
Target sample size	30

Research contact person
Name of lead principal investigator	Tsuyoshi Saito
Organization	Saitama Red Cross Hospital
Division name	Department of breast surgery
Address	8-3-33, Kamiochiai, Cyuo-ku, Saitama-city, Japan
TEL	048-852-1111
Email	tsaito@jcom.home.ne.jp

Public contact
Name of contact person	Tsuyoshi Saito
Organization	Saitama Red Cross Hospital
Division name	Department of breast surgery
Address	8-3-33, Kamiochiai, Cyuo-ku, S
TEL	048-852-1111
Homepage URL
Email	tsaito@jcom.home.ne.jp

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group
Institute
Department

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	さいたま赤十字病院，埼玉県立がんセンター，埼玉社会保険病院，自治医大さいたま医療センター

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 10 Month 08 Day
Anticipated trial start date	2013 Year 10 Month 15 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 10 Month 14 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014061