Unique ID issued by UMIN | UMIN000009035 |
---|---|
Receipt number | R000010602 |
Scientific Title | Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer |
Date of disclosure of the study information | 2012/10/03 |
Last modified on | 2020/04/09 09:14:11 |
Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer
PerSeUS-BC01
Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer
PerSeUS-BC01
Japan |
Resectable primary breast cancer
Breast surgery |
Malignancy
YES
Evaluation of the effectiveness and the safety of the following protocol; Phase II study of neoadjuvant chemotherapy with nab-Paclitaxel followed by EC for resectable primary breast cancer.
Safety,Efficacy
Phase II
Pathological complete response rate
pCR rate
Response rate
Histological therapeutic effect
Safety
Breast conserving rate
QOL
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
After 4 cycles of nab-Paclitaxel followed by 4 cycles of EC, surgical resection is carried out.
nab-Paclitaxel
(HER2 negative)
nab-Paclitaxel 260mg/m2 iv day1 q3w
(HER2 positive)
nab-Paclitaxel 260mg/m2 iv day1 q3w
Trastuzumab 6 mg/kg iv day1 q3w
(8 mg/kg in only first course)
EC
Epirubicin 90mg/m2 iv day 1 q3w
Cyclophosphamide 600mg/m2 iv day 1 q3w
20 | years-old | <= |
70 | years-old | > |
Female
1) Histologically confirmed breast cancer
2)ER positive, HER2 negative and Ki-67 >=15 or Nuclear grade 3
ER positive and HER2 positive
ER negative and HER2 positive
Triple negative
3)Clinical stage I-IIIB
4)Radical cure by operation and neoadjuvant chemotherapy
5) With measurable lesions
6) Age between 20 and 69 years at registration
7) Performance status of 0 or 1
8) With no prior surgery, radiotherapy, chemotherapy and endocrine therapy for breast cancer
9) Normal LVEF (LVEF> 50%) measured by the MUGA scan or the echocardiogram (HER2 positive)
10) Adequate organ function shown in physical examinations within 14 days before the registration
White blood cell count =>3000/mm3
Neutrophil count =>1500/mm3
Platelet count =>100000/mm3
Hemoglobin =>9.0g/dL
AST<= 2.5 x ULN
ALT <= 2.5 x ULN
Total bilirubin <=1.5mg/dL
Creatinine <=1.5mg/dL
Adequate cardiac function
11) Patient who undertook sentinel lymph node biopsy, if any
12)Written informed consent
1) Inflammatory, bilateral or mucinous breast cancer
2) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval
3) Severe complication(s), e.g., congestive cardiac failure, coronary failure, cardiac infarction, angina pectoris, arrhythmia, cerebrovascular disease, active gastrointestinal tract ulcer, diabetes, renal failure, hepatic failure, active hepatitis or hepatic cirrhosis.
4) Active infection
5) Interstitial pneumonitis or pulmonary fibrosis identified by chest radiography or chest CT
6) Positive for HBs antigen or HCV antibody
7) Uncontrollable peripheral neuropathy
8) History of drug allergy
9) Pregnant / nursing
10) Severe mental disorders
11) Disqualified by investigator
36
1st name | |
Middle name | |
Last name | Kazuhiro Yoshida |
Gifu University graduate school of medicine
Department of surgical oncology
1-1 Yanagido, Gifu city
058-230-6000
kyoshida@gofi-u.ac.jp
1st name | |
Middle name | |
Last name | Manabu Futamura |
Gifu University graduate school of medicine
Breast and molecular oncology
1-1 Yanagido, Gifu city
058-230-6000
mfutamur@gifu-u.ac.jp
PerSeUS:Perpetual Study estimated-by United Sections in Gifu
Gifu Univ
Dept of Surgical Oncology
Self funding
NO
2012 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2012 | Year | 05 | Month | 17 | Day |
2013 | Year | 02 | Month | 26 | Day |
2012 | Year | 05 | Month | 17 | Day |
2014 | Year | 09 | Month | 30 | Day |
2016 | Year | 04 | Month | 20 | Day |
2016 | Year | 12 | Month | 21 | Day |
2016 | Year | 12 | Month | 26 | Day |
2012 | Year | 10 | Month | 03 | Day |
2020 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010602
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |