UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006159 |
|---|---|
| Receipt number | R000007074 |
| Scientific Title | Phase II trial of Trastuzumab in combination with Abraxane for patients with HER2-positive metastatic breast cancer |
| Date of disclosure of the study information | 2011/08/15 |
| Last modified on | 2018/08/17 09:25:29 |
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Basic information
Public title
Phase II trial of Trastuzumab in combination with Abraxane for patients with HER2-positive metastatic breast cancer
Acronym
Trastuzumab/Abraxane for HER2-positive MBC
Scientific Title
Phase II trial of Trastuzumab in combination with Abraxane for patients with HER2-positive metastatic breast cancer
Scientific Title:Acronym
Trastuzumab/Abraxane for HER2-positive MBC
Region
| Japan |
Condition
Condition
HER2-positive Metastatic breast cancer
Classification by specialty
| Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of trastuzumab/Abraxane combination 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
Progression-free survival
Key secondary outcomes
Response rate
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
Abraxane: 260mg/m2, iv, day 1
Trastuzumab: 4mg/kg(loading dose) and then 2mg/kg, iv, day 1, 8, 15 or 8mg/kg(loading dose) and then 6mg/kg, iv, day 1, 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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically confirmed breast cancer with metastatic disease
2. Age are 20-75 years old
3. HER2 Overexpression (IHC3+) or HER2 gene amplification (FISH+)
4. No prior treatment with paclitaxel for metastatic breast cancer
5. with evaluable lesion
6. Performance status:0,1,2
7. LVEF>50%
8. Required baseline laboratory data(within 14 days of registration)
WBC >4,000 /mm3 or Neut >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 creatin< 1.5mg/dL
9. Expected survival time: more than 3 months
10. Written informed consent
Key exclusion criteria
(1)With history of hypersensitivity reaction for trastuzumab, paclitaxel and albumin
(2)With severe complication.
(3)Pregnant or nursing women.
(4)With widespread liver metastases or pulmonary lymphangitis with dyspnea
(5) with active another cancer
(6)with brain metastasis with symptom
(7)with uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 1 year, arrhythmia that need treat, valvular heart disease.
(8)with pulmonary fibrosis or pneumonitis.
(9)with dyspnea at rest (due to metastatic lung lesion and cardiovascular disease).
(10)with pleural effusion, ascites, and pericardial effusion that need treat
(11) Cases who physician judged improper to entry this trial
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwase |
Organization
Kumamoto University, Graduate School of Medical Sciences
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto, 862-8556, Japan
TEL
096-373-5521
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamamoto |
Organization
Kumamoto University, Graduate School of Medical Sciences
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto, 862-8556, Japan
TEL
096-373-5521
Homepage URL
breast@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto Breast Cancer Cooperative 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007074
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| Registered date | File name |
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| Registered date | File name |
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