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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035235
Receipt No. 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 2018/12/12

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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
Middle name
Last name Manabu Futamura
Organization Gifu University Graduate School of Medinine
Division name Department of Surgical Oncology
Zip code
Address 1-1 Yanagido, Gifu City
TEL 058-230-6000
Email mfutamur@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Futamura
Organization Gifu University Graduate School of Medinine
Division name Department of Surgical Oncology
Zip code
Address 1-1 Yanagido, Gifu City
TEL 058-230-6000
Homepage URL
Email mfutamur@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medinine
Department of Surgical Oncology
Institute
Department

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

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
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 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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 12 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040151

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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