UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008465 |
|---|---|
| Receipt number | R000009814 |
| Scientific Title | PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer |
| Date of disclosure of the study information | 2012/07/18 |
| Last modified on | 2018/07/13 10:20:24 |
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Basic information
Public title
PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Acronym
PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Scientific Title
PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Scientific Title:Acronym
PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Region
| Japan |
Condition
Condition
HER2 positive resectable primary breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate effectiveness and safety of Tri-Weekly nab Paclitaxel+Trastuzumab followed by FEC therapy as chemotherapy in preoperation for HER2-positive resectable primary breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Overall response rate
Breast conserving rate
Adverse events
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
Administrate 4 cycles of FEC after 4 cycles of nab Paclitaxel and Trastuzumab. Operation is to be performed after chemotherapy.
nab Paclitaxel and Trastuzumab 4 cycles
nab Paclitaxel 260mg/m2 iv day1 q3w
Trastuzumab 6 mg/kg iv day1 q3w
(8 mg/kg in only first course)
FEC 4 cycles
5-Fluorouracil 500mg/m2 iv day 1 q3w
Epirubicin 100mg/m2 iv day 1 q3w
Cyclophosphamide 500mg/m2 iv day 1 q3w
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically invasive breast cancer
2. Stage I-IIIA (T1c-3, N0-2a,M0)
3. An age of 20 years to 70 years
4. Hormonal receptor status is confirmed.
5. HER2 status, is confirmed.
1)IHC 3+
2) FISH score>2.2
6. PS 0-1
7. Measurable lesion according to RECIST standard
8. No prior treatment for breast cancer
9. LVEF more than 55%
10. Adequate EKG
11. Required baseline laboratory data
WBC > 4,000/mm3
Neut > 2,000/mm3
PLT > 100,000/mm3
Hb > 9.0g/dl
AST < ULNx2.5
ALT< ULNx2.5
T-Bil < 1.5mg/dl
Serum creatinin < 1.5mg/dl
12. Written informed consent
Key exclusion criteria
1. Current history of malignant neoplasm.
2. Bilateral invasive breast cancer.
3. Cases who does not wish to undergo an operation after neoadjuvant chemotherapy.
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus.
5. Has history of hypersensitivity reaction in important drug of this study.
6. Positive for HBs antigen.
7.
8. With severe peripheral neuropathy.
9. Transfusion within the past 2 weeks.
10. With the history of severe mental disease or under treatment.
11. With active pleural effusion or ascites.
12. Pregnancy, or suspected pregnancy.
13. Cases who physician judged improper to entry this trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Tokunaga |
Organization
Osaka City General Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL
06-6929-1221
s-tokunaga@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Tokunaga |
Organization
Osaka City General Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL
06-6929-1221
Homepage URL
s-tokunaga@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
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 | 07 | Month | 18 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009814
| 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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