UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006547 |
|---|---|
| Receipt number | R000007757 |
| Scientific Title | Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer. |
| Date of disclosure of the study information | 2011/10/16 |
| Last modified on | 2019/10/17 08:09:04 |
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Basic information
Public title
Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Acronym
Nature study
Scientific Title
Phase II study of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Scientific Title:Acronym
Nature study
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effficacy and safety of q3w nab-paclitaxel in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Safety
Overall survival
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
Abraxane: 260mg/m2, iv, day 1
Every 3 weeks
Trastuzumab: 6mg/kg, iv, day1
Every 3 weeks
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. Histologically confirmed
metastatic breast cancer.
2. Age are more than 20 years old
3. within withiin 2 prior treatment for metastatic breast cancer.
4. With evaluable leasion
5. Performance statu is 0,1,2.
6. Required baseline laboratory data. (within 14 days of registration)
WBC > 4,000 /mm3 or Neu > 2,000/mm3
PLT > 100,000 /mm3
Hb > 9.0 g/dL
ALT and AST < ULNx2.5
ALT and AST < ULNx2.5
T-Bil < 1.5mg/dL
serum creatine < 1.5mg/dL
7. Expected survival time: more than 6 months.
8.Written informed- consent
Key exclusion criteria
1. With history of hypersensitivity reaction for paclitaxel and/or albumin and/or trastuzumab.
2. With severe complications.
3. Pregnant or nursing women.
4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis.
5. With severe complications.
6. With brain metastasis.
7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease.
8. With pulmonary fibrosis or pneumonitis.
9. With dyspnea at rest.
10. With pleural effusion, ascites, pericardial effusion.
11. Doctor's decision not to be registered to this study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Takenoshita |
Organization
Fukushima Medical University School of medicine
Division name
Department of Surgery
Zip code
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1259
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Ohtake |
Organization
Fukushima Medical University School of medicine
Division name
Department of Surgery, Division of Breast Surgery
Zip code
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1259
Homepage URL
trcyn@cc.fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of medicine
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
公立大学法人福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 16 | 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
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007757
