Unique ID issued by UMIN | UMIN000020693 |
---|---|
Receipt number | R000023875 |
Scientific Title | Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2019/07/26 05:21:53 |
Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Phase2 study of dose dense EC followed Nab-PTXas neoadjuvant chemotherapy for HER2-negative primary breast cancer
Japan |
breast cancer
Breast surgery |
Malignancy
NO
To evaluate the efficacy and safety of preoperative administration of Dose dense biweekly Epirubicine and Cyclophosphamide (EC therapy) of 4 cycles followed by nab-PTX of 4 cycles in patients with HER2 negative operable breast cancer.
Safety,Efficacy
pathological complete response
response rate
the rates of breast conserving surgery
dosease free survival
overall survival
side effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administrate 4 cycles of dose dense EC therapy(Epirubicine and Cyclophosphamide) followed by 4 cycles of nab-PTX. Operation is to be performed after chemotherapy.
EC(, Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2) intravenously on day 1 of each 2-weeks
nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 3-weeks.
20 | years-old | <= |
75 | years-old | >= |
Female
1) Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T2-4 any N M0)
2)luminal B(ER positive,Ki67index>=20%) or Triple negative(ER negative PgR negative HER2 negative)
3)Age between 20 to 75 years old
4)ECOG performance status (PS): 0-1
5)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
6)Results from a laboratory test meet the following:
a)Leukocyte count is >=3000/mm3 or
b)Neutrophil count is >=2000/mm3
c)Hemoglobin >=9.0g/dL
d)Platelet >=100 000/mm3
e)AST and ALT <=x 2.0 of upper limit of normal (ULN)
f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN
g)Serum creatinine <=x 1.5 of ULN
7)Signed written informed consent
1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding).
2)Multiple primary cancer
3)Synchronous bilateral breast cancer
4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan.
5)Women who are pregnant, lactating or with childbearing potential
6)Hypersensitivity to any agents necessary in the planned treatment.
7)Serious peripheral neuropathy or serious edema
8)Pleural effusion or cardiac effusion which requires treatment
9)Complication which requires prior treatment with corticosteroid
10)Suspected infection
11)Ineligible based on decision of an investigator
50
1st name | Tetsuya |
Middle name | Tetsuya Taguchi |
Last name | Taguchi |
Kyoto Prefectural University of Medicine
Endocrine & Breast Surgery
602-8566
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
075-251-5534
ttaguchi@koto.kpu-m.ac.jp
1st name | Ayana |
Middle name | Ayana Sakuramachi |
Last name | Sakuramachi |
Kyoto Prefectural University of Medicine
Endocrine & Breast Surgery
602-8566
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
075-251-5534
ayana-s@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Kyoto Prefectural University of Medicine
Endocrine & Breast Surgery
Self funding
Kyoto Prefectural University of Medicine Endocrine & Breast Surgery IRB
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 465
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
2016 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 04 | Month | 19 | Day |
2016 | Year | 05 | Month | 01 | Day |
2021 | Year | 05 | Month | 01 | Day |
2016 | Year | 01 | Month | 21 | Day |
2019 | Year | 07 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023875