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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006547
Receipt No. 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

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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
Email

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
Email trcyn@cc.fmu.ac.jp

Sponsor
Institute Fukushima Medical University School of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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