Unique ID issued by UMIN | UMIN000001205 |
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Receipt number | R000001470 |
Scientific Title | Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP) |
Date of disclosure of the study information | 2008/06/21 |
Last modified on | 2018/12/18 19:53:20 |
Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Phase II study of weekly paclitaxel (wP) followed by doxorubicin plus paclitaxel (AP) as neo-adjuvant chemotherapy for triple negative Breast Cancer (WePAP)
Japan |
Primary breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
Evaluate the efficacy and the safety for the treatment of weekly paclitaxel (wPTX) followed by doxorubicin(ADM) plus paclitaxel in neo-adjuvant chemotherapy for Breast Cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Pathological complete response; pCR rate
Clinical response rate
Disease free survival
Overall survival
Breast conserving rate
Treatment compliance
Biomarkers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
12 cycles of wPTX followed by 4 cycles of ADM+PTX (AP)
PTX 80mg/m2 12 cycles
1) day1; PTX 80mg/m2
after completion wPTX, day22 would be day1 and followed by AP 4 cycles
(q3weeks)
1) day1; ADM 50mg/m2
2) day1; PTX 150mg/m2
20 | years-old | <= |
Not applicable |
Female
1)Histologically confirmed primary breast cancer
2)Tumor diamiter >2cm or Node positive
3) No prior chemotherapy for breast cancer
4) Age >20 y
5)ECOG PS 0-1
6)Hormone receptor negative;
ER(-) and PgR(-), less than 10% by immunohistochemistry
7)HER2 negative (<1 by HercepTest, if 2+ by HercepTest, Signal ratio <2.0 by FISH)
8) Written informed consent
9) No operation for breast cancer
10) Adequate main organ functions
1)Severe complication
2)Inflammatory breast caner and male breast cancer
3)Ischemic heart disease or arrhythmia which needs medical treatment (history of myocardial infarction occured within 6 months)
4)Uncontrolled diabetes
5)Suspicious of infection
6)History of serious hypersensitivity or history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate
7)During pregnancy or lactation
8)Patient judged inappropriate by physicians
63
1st name | |
Middle name | |
Last name | Toshio Tabei |
Saitama Cancer Center
Breast Medical Oncology
818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan
048-722-1111
toshikai@sbccsg.org
1st name | |
Middle name | |
Last name | Toshihiro Kai |
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Secretariat Division (Shintoshin Ladies' MammoClinic)
3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
048-600-1722
http://www.sbccsg.org/
toshikai@sbccsg.org
Saitama Breast Cancer Clinical Study Group (SBCCSG)
none
Self funding
NO
2008 | Year | 06 | Month | 21 | Day |
Unpublished
No longer recruiting
2008 | Year | 04 | Month | 07 | Day |
2008 | Year | 06 | Month | 01 | Day |
2019 | Year | 04 | Month | 01 | Day |
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 08 | Month | 01 | Day |
2020 | Year | 03 | Month | 30 | Day |
2008 | Year | 06 | Month | 20 | Day |
2018 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001470
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