UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013607 |
|---|---|
| Receipt number | R000015893 |
| Scientific Title | Observational study of Pertuzumab,Trastuzumab and taxane combination therapy for patient with pretreated HER2-positive advanced or recurrent breast cancer. |
| Date of disclosure of the study information | 2014/04/02 |
| Last modified on | 2017/04/05 08:44:47 |
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Basic information
Public title
Observational study of Pertuzumab,Trastuzumab and taxane combination therapy for patient with pretreated HER2-positive advanced or recurrent breast cancer.
Acronym
Observational study of Pertuzumab combination therapy for pretreated HER2-positive MBC.
Scientific Title
Observational study of Pertuzumab,Trastuzumab and taxane combination therapy for patient with pretreated HER2-positive advanced or recurrent breast cancer.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Rai Shimoyama |
Organization
Shonankamakura General Hospital
Division name
General surgery
Zip code
Address
1370-1 Okamoto,Kamakura city, Kanagawa
TEL
0467-46-1717
rai.shimoyama@tokushukai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rai Shimoyama |
Organization
Shonankamakura General Hospital
Division name
Clinical Research Center
Zip code
Address
1370-1 Okamoto,Kamakura city, Kanagawa
TEL
0467-46-1717
Homepage URL
rai.shimoyama@tokushukai.jp
Sponsor or person
Institute
Shonankamakura General Hospital
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
none
Name of secondary funder(s)
none
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
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015893
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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