UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012030 |
|---|---|
| Receipt number | 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 18:10:03 |
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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
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
tsaito@jcom.home.ne.jp
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014061
