UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012208 |
|---|---|
| Receipt number | R000014275 |
| Scientific Title | A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy. |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2016/05/16 11:50:39 |
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Basic information
Public title
A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Acronym
A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Scientific Title
A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Scientific Title:Acronym
A phase II trial of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of pertuzumab and trastuzumab in combination with capecitabine in patients with metastatic breast cancer who received prior trastuzumab combination chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression-free survival
Overall survival
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
Pertuzumab:840mg/body intravenously administred on day 1 every 3 weeks (loading dose:840mg/body)
Trastuzumab:6mg/kg intravenously administred on day 1 every 3 weeks (loading dose:8mg/kg)
Capecitabine:2,000 mg/m2/day orally in 2 divided doses for 2 weeks followed by 1week rest
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically confirmed breast cancer.
2) HER2-positive(3+ staining by IHC or HER2 gene amplification by FISH) metastatic breast cancer.
3) Patients with at least one or more prior chemotherapy combined trastuzumab.
4) No prior treatment by capecitabine for present primary breast cancer.
5) Patients with measurable lesion.
6) Left ventricle ejection fraction 50% or over by cardiac sonography within 28 days prior to entry.
7) Age between 20 and 70 years.
8) ECOG performance status 0 to 2.
9) Expected survival longer than 3 months.
10) Sufficient functions of important organs
WBC>=3,000/mm3
Neurtophils>=1,500/mm3
Platelets>=80,000/mm3
Hemoglobin>=9.0g/dl
AST<=2.0 X ULN
ALT<=2.0 X ULN
Total bilirubin<=2.0mg/dl
Creatinine<=2.0mg/dl
11) All of HBs antigen, HBs antibody, HBc antibody and HCV antibody are negative.
12) Written informed consent to participate.
Key exclusion criteria
1) History of hypersensitivity reaction
2) Brain metastasis
3) Pleural effusion, ascites, and pericardial fluid requiring treatment
4) Active another cancer
5) Active infection
6) Other severe complications, such as heart failure, interstitial pneumonia and renal failure with clinically problem
7) Required treatment with steroid
8) Pregnant or possibility pregnancy or nursing women
9) Mental disorder which become problem on clinical practice
10) Physician judged improper to entry this trial
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Miwa |
Organization
Kurume University Hospital
Division name
Cancer Multidisciplinary Treatment Center
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
miwakeisuke@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Miwa |
Organization
Kurume University Hospital
Division name
Cancer Multidisciplinary Treatment Center
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-35-3311
Homepage URL
miwakeisuke@gmail.com
Sponsor or person
Institute
Kurume University 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
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
久留米大学病院(福岡県)、社会保険久留米第一病院(福岡県)、国立病院機構九州医療センター(福岡県)、公立八女総合病院企業団(福岡県)、大牟田市立総合病院(福岡県)、聖マリア病院(福岡県)、大分県済生会日田病院(大分県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | 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 | 11 | Month | 04 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014275
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