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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012030
Receipt No. R000014061
Scientific Title A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Date of disclosure of the study information 2013/10/15
Last modified on 2017/11/30

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Basic information
Public title A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Acronym A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Scientific Title A Phase II study of pertuzumab+trastuzumab+capecitabine in Patients with taxans and trastuzumab refractory for advanced or recurrent breast cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Tsuyoshi Saito
Organization Saitama Red Cross Hospital
Division name Department of breast surgery
Zip code
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
1st name
Middle name
Last name Tsuyoshi Saito
Organization Saitama Red Cross Hospital
Division name Department of breast surgery
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 08 Day
Date of IRB
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

Other
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

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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