UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035235 |
|---|---|
| Receipt number | R000040151 |
| Scientific Title | nab-Paclitaxel plus trastuzumab and pertuzumab followed by EC as a neoadjuvant chemotherapy for HER2-positive operable breast cancer |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2023/12/16 14:16:17 |
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Basic information
Public title
nab-Paclitaxel plus trastuzumab and pertuzumab followed by EC as a neoadjuvant chemotherapy for HER2-positive operable breast cancer
Acronym
PerSeUS-BC04
Scientific Title
nab-Paclitaxel plus trastuzumab and pertuzumab followed by EC as a neoadjuvant chemotherapy for HER2-positive operable breast cancer
Scientific Title:Acronym
PerSeUS-BC04
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of nab-Paclitaxel followed by EC for HER2-positibe operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pCR rate
Key secondary outcomes
Response rate
Pathological evaluaion
Breast conserving rate
Safety (change of LVEF, CIPN etc)
Evaluation after 4 cycles of nabPTX/TZ/PER
RDI
Adjuvant therapy
DFS
OS
Evaluation of TILs/SPARC in biopsy samples
Analysis of tumor-rekated factors in urine and blood(Pre, after 4*nabPTX, after 4*EC)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Nab-paclitaxel(260mg/m2)
Trastuzumab( 1st: 8mg/kg, 2nd: 6mg/kg)
Pertuzumab (1st 840mg, 2nd 420mg)
4 courses (3qw)
2.Epirubicin (90mg/m2)
Cyclophosphamide (600mg/m2)
4 courses (3qw)
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) Patients with breast cancer
2) HER2-type Luminal/HER2 type
3)Stage I-IIIB
4)Curable by neoadjuvant chemotherapy and surgery
5) cases with measurable lesion
6) age 20-69 at registration
7) PS(ECOG) 0-1
8) No therapy before registration
9) LVEF >50% by UCG
10)
WBC >3,000/mm3
Neutrophil >1,500/mm3
Platelet >100,000/mm3
Hb >9.0 g/dL
AST(GOT) <ULN x3
ALT(GPT) <ULN x3
T-Bil <2 mg/dL
Cr <2 mg/dL
11) Informed consent obtained from IC
12) To evaluate lymph node, not only CT/PET/US, but sentinel node biopsy/cytology may be preferable.
Key exclusion criteria
1)Inflammatory and/or bilateral breast cancer
2)Duplicated/sunchromus/metachromus cancer(DFS less than 5y)
3)Severe complication (cardiovascular, lung, liver disease, homorragic ulcer etc.)
4)febrile, susupicious for infection
5)Interstitial pneumonia or pulmonary fibrosis by chest-X/CT
6)Active systhemic infevtion (HBV, HCV, HIV etc.)
7)Uncontrollable pheripheral pneuropathy due to DM, V-12 deficiency etc.
8)Severe allergy to drug
9)Pregnancy, Lactation
10)Uncontrollable mental disease
11)Not suitable for this study judged by physician/Surgeon
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Gifu University Graduate School of Medinine
Division name
Department of Surgical Oncology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6000
mfutamur@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Futamura |
Organization
Gifu University Graduate School of Medinine
Division name
Department of Surgical Oncology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6000
Homepage URL
mfutamur@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Department of Surgical Oncology
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medinine
PerSeUS BC studies
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Gihoku kosei hospital
Gifu municipal hospital
Gifu prefectual general medical center
Ibi kosei hospital
Municipal Ena hospital
Daiyukai general hospital
Asahi Univ. hospital
Takayama red rross hospital
Kizawa memorial hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central ethics committee of Gifu University
Address
1-1 Yanagido Gifu
Tel
+81582306000
rinri@gifu-u.ac.jp
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
Gifu Univ. Hospital
Gihoku kosei hospital
Gifu municipal hospital
Gifu prefectual general medical center
Ibi kosei hospital
Municipal Ena hospital
Daiyukai general hospital
Asahi Univ. hospital
Takayama red rross hospital
Kizawa memorial hospital
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 12 | 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
| Delay expected |
Results Delay Reason
Statistics is ongoing
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 30 | Day |
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
| 2018 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040151
| 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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