Unique ID issued by UMIN | UMIN000040187 |
---|---|
Receipt number | R000045822 |
Scientific Title | dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2023/10/20 18:04:13 |
dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer
PerSeUS-BC05
dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer
PerSeUS-BC05
Japan |
Breasr cancer
Breast surgery |
Malignancy
NO
To investigate the efficacy and safety of dose-dense AC therapy followed by dose-dense paclitaxel for triple negative operable breast cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
pCR rate
Response rate
Pathological evaluation
Breast conserving rate
Safety(change of LVEF,Febrile neutropenia,CIPN,Pneumocystis pneumonia)
Relative dose intensity
Aduvant therapy
DFS
OS
Evaluation of TILs/PD-L1 in biopsy samples
Analysis of tumor-related factors in urine and blood(Pre,after 4*dose-dense AC or EC, after*4 dose-dense paclitaxel)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
1
Treatment
Medicine |
1.dose-dense Adriamycin(60mg/m2),cyclophospamide(600mg/m2)or Epirubicin90mg/m2,cyclophosphamide(600mg/m2)
4courses(2qw)
2.dose-dense paclitaxel(175mg/m2)
4courses(2qw)
20 | years-old | <= |
70 | years-old | > |
Female
1)Patients with breast cancer
2)triple negative typr
3)StageI-IIIB
4)Curable by neoadjuvant chemotherapy ans surgery
5)cases with measurable lesion
6)age20-69 at registration
7)PS(ECOG)0-1
8)No therapy before registration
9)LVEF>50% by UCG
10)WBC>3000/mm3
Neutrophil>1500/mm3
Platelet<10,000/mm3
Hb>9.0g/dL
AST(GOT)<ULNx3
ALT(GPT)<ULNx3
T-Bil<2mg/dL
Cr<2mg/dL
11)informed consent obtained from IC
12)To evaluate lymph node, not only CT/PET/US, but sentinel node biopsy/cytligy may be preferable.
1)inflammamatory 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, suspicious for infection
5)Intedstitial pneumonia oe pulmonary fibrosis by chest-X/CT
6)Active systhemic infection()HBV,HCV,HIC etc.)
7)Severe allergy to drug
8)Pregnancy,Lactation
9)Uncontrollable mental disease
10)Not suitable for thes study judged by physician/Surgeon
35
1st name | Manabu |
Middle name | |
Last name | Futamura |
Gifu University Graduate School of Medicine
Department of Surgical Oncology
501-1194
1-1 Yanaido, Gifu City
058-230-6000
mfutamur@gifu-u.ac.jp
1st name | Yoshimi |
Middle name | |
Last name | Asano |
Gifu University Graduate School of Medicine
Department of Surgical Oncology
501-1194
1-1 Yanaido, Gifu City
058-230-6000
yasano@gifu-u.ac.jp
Gifu University Graduate School of Medicine
Department of Surgical Oncology
Gifu University Graduate School of Medicine
Department of Surgical Oncology
Government offices of other countries
Gihoku kosei hospital
Gifu municipal hospital
Gifu prefectual general medical center
Ibi kosei hospital
Daiyukai general hospital
Takayama red cross hospital
Kizawa memorial hospital
Asahi Univ.hospital
ifu University Graduate School of Medicine Department of Ethics and Social Medicine
1-1 Yanaido, Gifu City
058-230-6059
rinri@gifu-u.ac.jp
NO
Gihoku kosei hospital
Gifu municipal hospital
Gifu prefectual general medical center
Ibi kosei hospital
Daiyukai general hospital
Takayama red cross hospital
Kizawa memorial hospital
Asahi Univ.hospital
2020 | Year | 06 | Month | 01 | Day |
Unpublished
Preinitiation
2020 | Year | 04 | Month | 09 | Day |
2020 | Year | 04 | Month | 09 | Day |
2020 | Year | 06 | Month | 01 | Day |
2022 | Year | 05 | Month | 31 | Day |
The study has been cancelled due to lack of approval by our ethics review. The date of approval by the Ethics Committee is tentative.
2020 | Year | 04 | Month | 17 | Day |
2023 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045822
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