Unique ID issued by UMIN | UMIN000001736 |
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Receipt number | R000002019 |
Scientific Title | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) |
Date of disclosure of the study information | 2009/02/27 |
Last modified on | 2018/05/14 16:51:23 |
Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801)
Japan |
Primary breast cancer
Medicine in general | Surgery in general | Breast surgery |
Malignancy
NO
Clinical & pathological response and safety profile of neoadjuvant chemotherapy consisting of sequential treatment with paclitaxel monotherapy followed by FEC regimen for patients with primary breast cancer.
Safety,Efficacy
Confirmatory
Pragmatic
Pathological complete response rate
Safety
Clinical efficacy
Overall survival
Disease free survival
Breast-conserving rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Paclitaxel 80mg/m2 every week for 12 cycles.
5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles.
Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy.
20 | years-old | <= |
Not applicable |
Female
1.Histologicaly-proven primary resectable breast cancer with a tumor size of >=1cm and clinical stage of <=IIIA
2. No history of chemotherapy
3. No history of surgery, radiotherapy, hormonal therapy against breast cancer
4. ECOG PS 0, 1
5. Sufficient organ function
6. Written informed consent
1. Severe medical conditions
2. Suspected infectious disease
3. Alergy to clemohol EL
4. Severe peripheral neuropathy
5. Pregnant or lactating women
32
1st name | |
Middle name | |
Last name | Maki Tanaka |
Kurume Daiichi Social Insurance Hospital
Surgery
21 Kushihara-Cho, Kurume
0942-33-1211
maki@tanaka.name
1st name | |
Middle name | |
Last name | Kazuo Tamura |
Kyushu Breast Cancer Study Group
Executive office
1-8-17-204, Watanabe-dori, Chuo-ku, Fukuoka
092-406-4166
http://www.chotsg.com
npo@chotsg.com
Kyushu Breast Cancer Study Group
Non-profit Organization Clinical Hematology/Oncology Study Group
Non profit foundation
Japan
NO
2009 | Year | 02 | Month | 27 | Day |
http://www.chotsg.com
Unpublished
Completed
2008 | Year | 06 | Month | 18 | Day |
2008 | Year | 09 | Month | 01 | Day |
2015 | Year | 08 | Month | 01 | Day |
2009 | Year | 02 | Month | 25 | Day |
2018 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002019
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