UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007600 |
|---|---|
| Receipt number | R000008968 |
| Scientific Title | Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/03/30 08:34:32 |
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Basic information
Public title
Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer
Acronym
Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer
Scientific Title
Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer
Scientific Title:Acronym
Phase I/II study of Chemotherapy with Nab-paclitaxel, Carboplatin and Trastuzumab in HER2-positive Locally Advanced Breast Cancer
Region
| Japan |
Condition
Condition
Locally advanced breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficency in Phase I and II as combined chemotherapy of nab-paclitaxel, carboplatine, and trastzumab in HER2 positive locally advanced breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Maximum tolerated dose and recommended dose in phase I study
Respose rate in phase II study
Key secondary outcomes
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
Nab-paclitaxel
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)Patinets with a histopathological diagnosis of invasive breast cancer
2)Women for an initial diagnosis of IIIB or stage IIIC breast cancer
3)An age of 20 years to 70 years
4)Having at least one measureable lesion
5)HER2 status,IHC 3+ or FISH score>2.2, is comfirmed by biopsy specimen
6)Baseline left ventricular ejection fraction (LVEF) => 55% measured by echocardiography or MUGA scan. (comfirmed within 28 days before ragistration)
7)No clinical problem is found in ECG (comfirmed within 28 days before registraion)
8)ECOG performance status is 0 or 1
9)Adequate organ functions confirmed with following major examination
WBC=>4000mm3
Neutrophil=>2000mm3
Platelet count=>100,000/mm3
Hemoglobin=>9.0g/dL
AST,ALT=<100IU/L
Total bilirubin=<1.5mg/dL
Serum creatinine=<1.5mg/dL
Albmin=>3.0mg/dL
10)Obtained written informed consent
Key exclusion criteria
1)With history of hypersensitivity reaction for important medications in this treatment
2)Inflammatory breast cancer(T4d)
3)Synchronous double cancer (carcinoma in situ) which is controllable by local treatment is excluded
4)With uncontrollable infectious disease, diarrhea, ileus, diabetes, or other serious complications
5)With active pleural effusion or ascites
6)With serious heart disease, or the patient who has past history of it
7)With severe peripheral nerve disorder
8)With GI ulcer or GI hemorrhage
9)Having a past history of severe mental disorder or the patient who is under treatment of it
10)Pregnancy, or suspected pregnancy
11)HBs antigen positive or the patient for whom deoxyribonucleic acid analog is needed
12)Cases who physician judged improper to entry this trial
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tezuka |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Department of Breast Surgery
Zip code
Address
1180 Nagasonemachi Kita-ku Sakai-shi Osaka
TEL
072-252-3021
kntezuka@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Division name
Executive office
Zip code
Address
1-4-3 Asahimachi Abeno-ku Osaka-shi Osaka
TEL
06-6645-3838
Homepage URL
tsutomu-@rd5.so-net.ne.jp
Sponsor or person
Institute
Department of Surgical Oncology, Osaka City University Graduate 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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 29 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008968
| 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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