UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019616 |
|---|---|
| Receipt number | R000022429 |
| Scientific Title | Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer |
| Date of disclosure of the study information | 2015/11/04 |
| Last modified on | 2019/05/07 11:36:36 |
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Basic information
Public title
Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
Acronym
Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer
Scientific Title
Phase II study of neoadjuvant nab-paclitaxel and trastuzumab for ER negative and HER2 positive breast cancer
Scientific Title:Acronym
Neoadjuvant nab-PTX and trastuzumab for ER negative and HER2 positive breast cancer
Region
| Japan |
Condition
Condition
ER negative and HER2 positive breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of nab-paclitavel (PTX) and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Pathologic complete response rate (Up to 12 weeks after the protocol therapy)
Key secondary outcomes
Disease free survival
Objective response rate
Pathologocal response rate
Rate of breast conserving surgery
Safety profile
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
Four cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the
loading dose).
One year of adjuvant trastuzumab will be
administrated.
Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen.
Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
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. Histologically confirmed invasive breast cancer
2. Tumor size of 3cm or less and N0
3. Hormone receptors have been identified as negative
4. HER2 positive confirmed by IHC 3+ or FISH+
5. LVEF > 50% by echocardiogram or MUGA
6. Adequate EKG
7. No prior treatment for breast cancer
8. PS 0-1
9. Required baseline laboratory data
WBC > 4,000/mm3 and Neut > 2,000/mm3
PLT > 100,000/mm3
Hb > 9.0g/dl
AST and ALT < ULNx2.5
T-Bil < 1.5mg/dl
Serum creatinin < 1.5mg/dl
10. Written informed consent
Key exclusion criteria
1. With history of hypersensitivity reaction for important drug in this study
2. With history of invasive breast cancer
3. Bilateral invasive breast cancer
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
5. Positive for HBs antigen or HCV antibody
6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
7. With severe edema
8. With severe peripheral neuropathy
9. With severe psychiatric disorder
10. Pregnant or nursing women
11. The case that is judged to be unsuitable for this study by physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Iwamoto |
Organization
Osaka Medical College Hospital
Division name
Breast and endocrine surgery
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
TEL
0726831221
sur067@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Tanaka |
Organization
Osakaminami Medical Center
Division name
Breast surgery
Zip code
5868521
Address
2-1 Kidohigashicho, Kawachinagano, Osaka 586-8521, Japan
TEL
0721-53-5761
Homepage URL
sur112@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
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
Review board of Osaka Medical College
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
Tel
0726831221
rinri@osaka-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02598310
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
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
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 03 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022429
