UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005210 |
|---|---|
| Receipt number | R000006191 |
| Scientific Title | Neoadjuvant trastuzumab and nab-paclitaxel for HER2 positive breast cancer. |
| Date of disclosure of the study information | 2011/03/10 |
| Last modified on | 2011/03/07 22:52:29 |
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Basic information
Public title
Neoadjuvant trastuzumab and nab-paclitaxel for HER2 positive breast cancer.
Acronym
Neoadjuvant trastuzumab and nab-paclitaxel for HER2 positive breast cancer.
Scientific Title
Neoadjuvant trastuzumab and nab-paclitaxel for HER2 positive breast cancer.
Scientific Title:Acronym
Neoadjuvant trastuzumab and nab-paclitaxel for HER2 positive breast cancer.
Region
| Japan |
Condition
Condition
HER2 positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effficacy and safety of trastuzumab with nab-paclitaxel as neoadjuvant chemotherapy for HER2 positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint : The pathological CR rate
Key secondary outcomes
Secondary endpoint : The clinical response rate, adverse event, breast conserving rate and relapse free survival.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After enrollment, all patients receive preoperative treatment consisting of trastuzumab (4 mg/kg loading dose and then 2 mg/kg weekly for 11 weeks) and 260mg/m2
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Histologically confirmed breast cancer
2) Clinical stage I-III
3) HER2 Overexpression (IHC 3+ or FISH +)
4) No prior treatment for breast cancer
5) Age more than 20 years and less than 75 years
6) ECOG performance status of 0 or 1
7) Required baseline laboratory parameters (within 14 days of registration)
WBC: more than 3500 /mm3
Neu: more than 2,000 / mm3
Plt: more than 100,000/mm3
Hb: more than 9.0g/dl
AST: less than 1.5 times UNL
ALT: less than 1.5 times UNL
T-Bil: less than 1.5 times UNL
Cre: less than 1.5 times UNL
8) LVEF more than 55%
9) Written informed- consent
Key exclusion criteria
1) During pregnancy or lactation
2) Previous (written 5 years) or current history of malignant neoplasm
3) Sever bone marrow suppression, renal dysfunction, and liver dysfunction .
4) Long-term corticosteroid therapy
5) Sever cardiovascular or pulmonary disease.
6) Drug allergy to nab-paclitaxel or paclitaxel and albumin.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
+81333531211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
+81333531211
Homepage URL
jinno@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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 | 03 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 07 | Day |
Last modified on
| 2011 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006191
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