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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007600
Receipt No. 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

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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
Email 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
Email tsutomu-@rd5.so-net.ne.jp

Sponsor
Institute Department of Surgical Oncology, Osaka City University Graduate 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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008968

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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