UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of Pertuzumab,Trastuzumab and taxane combination therapy for patient with pretreated HER2-positive advanced or recurrent breast cancer.
Title of the study (Brief title)	Observational study of Pertuzumab combination therapy for pretreated HER2-positive MBC.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of the study was to assess the efficacy and the safety of Pertuzumab,Trastuzumab and taxane combination therapy for HER2-positive advanced or recurrent breast cancer with the history of Trastuzumab therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time to progression
Key secondary outcomes	Response rate Duration of treatment without taxane Safety

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	Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses.In case with paclitaxel,Trastusumab with a starting dose of 4 mg/kg followed by 2mg/kg as the second and subsequent doses. Docetaxel with a dose of 75 mg/m2 every 3 weeks, paclitaxel with a dose of 80mg/m2 every week, album n binding paclitaxel with a dose of 260mg/m2 every 3 week.
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed advancer (stave IIIB,IIIC,IV) or recurrent breast cancer. 2) Her2 positive breast cancer 3) Patient with history of Trasutuzumab treatment. 4) Patient without prior Pertuzumab treatment. 5) Patient with lesion confirmed by imaging tests 6) Patient with ECOG performance satis 0 or 1 7) Age 18 to 80 yeas old. 8) Patients with adequately maintained organ and bone marrow functions. 9) Any sex 19) Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria	1) Patient with history of severe allergy. 2) Patient with history of Pertuzumab treatment. 3) Patient with other malignancy under treatment. 4) Patient with active infectious disease. 5) Patient with severe complications, 6) Patient with history of interstitial neumonitis to pulmonary fibrosis. 7) Patient with uncontrollable pleural effusion or ascites. 8) Patient with symptomatic brain metastasis. 9) Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception. 10) Patient with psychiatric disease who were considered to be inappropriate. 11)Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Target sample size	50

Research contact person
Name of lead principal investigator	Rai Shimoyama
Organization	Shonankamakura General Hospital
Division name	General surgery
Address	1370-1 Okamoto,Kamakura city, Kanagawa
TEL	0467-46-1717
Email	rai.shimoyama@tokushukai.jp

Public contact
Name of contact person	Rai Shimoyama
Organization	Shonankamakura General Hospital
Division name	Clinical Research Center
Address	1370-1 Okamoto,Kamakura city, Kanagawa
TEL	0467-46-1717
Homepage URL
Email	rai.shimoyama@tokushukai.jp

Sponsor
Institute	Shonankamakura General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	湘南鎌倉総合病院（神奈川県）、東京西徳洲会病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 17 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 02 Day
Last modified on	2017 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015893