Unique ID issued by UMIN | UMIN000007648 |
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Receipt number | R000009019 |
Scientific Title | A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer |
Date of disclosure of the study information | 2012/04/02 |
Last modified on | 2016/05/11 10:13:04 |
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer
EC-wnabPTX as NAC PII
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer
EC-wnabPTX as NAC PII
Japan |
breast cancer
Breast surgery |
Malignancy
NO
The aim of this phase II study is to evaluate the efficacy and toxicity of EC (epirubicin/cyclophosphamide) followed by weekly nab-PTX with or without trastuzumab as a neoadjuvant therapy for the treatment of node-positive breast cancer.
Safety,Efficacy
Exploratory
Explanatory
Phase II
pathological CR(pCR rate)
the breast conserving rate, toxicities, feasibility and overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
In HER2negative cases, EC(E90mg/m2, C600mg/m2 4courses) followed by weekly nab-PTX(125mg/m2 on day1,8,15 in 28days 4courses) as a neoadjuvant therapy.
In HER2 posotive cases, EC(E90mg/m2, C600mg/m2 4courses) followed by weekly nab-PTX(125mg/m2 on day1,8,15 in 28days 4courses. weekly trastuzumab 2mg/kg) as a neoadjuvant therapy.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
Patients with histologically diagnosed invasive breast cancer
Resectable case
Category of the T1-4 N1-3
Without previous operation or chemotherapy
With measurable lesions
ECOG performance status 0-2
Adequate organ function
Written informed concent
Severe complications
history of hypersensitivity reaction for important drug in this study
Bilateral breast cancer
Inflammatory breast cancer
Pregnant or nursing women
56
1st name | |
Middle name | |
Last name | Tadao Shimizu |
Tokyo Women's Medical University, Medical Center East
Department of Breast Surgery
2-1-10, Nishi-ogu, Arakawa-ku,
03-3810-1111
shimitsu@dnh.twmu.ac.jp
1st name | |
Middle name | |
Last name | Akira Hirano |
Tokyo Women's Medical University, Medical Center East
Department of Breast Surgery
2-1-10, Nishi-ogu, Arakawa-ku,
03-3810-1111
ahirasu@dnh.twmu.ac.jp
Tokyo Women's Medical University
None
Self funding
Tokyo Women's Medical University, Yachiyo Medical Center
NO
東京女子医科大学東医療センター(東京都)、八千代医療センター(千葉県)
2012 | Year | 04 | Month | 02 | Day |
Unpublished
No longer recruiting
2011 | Year | 03 | Month | 14 | Day |
2011 | Year | 04 | Month | 01 | Day |
2018 | Year | 03 | Month | 01 | Day |
2012 | Year | 04 | Month | 02 | Day |
2016 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009019
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