Unique ID issued by UMIN | UMIN000005979 |
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Receipt number | R000007073 |
Scientific Title | Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Breast Cancer |
Date of disclosure of the study information | 2011/07/15 |
Last modified on | 2011/07/15 15:50:46 |
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Breast Cancer
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Breast Cancer
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Breast Cancer
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Breast Cancer
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To investigate the efficacy and safety of weekly Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for breast cancer
Efficacy
Pathological complete response rate
Response rate
Breast conserving rate
Adverse event
Rate of patients with residual peripheral neuropathy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Nab-paclitaxel followed by FEC
Nab-paclitaxel 100 mg/m2 i.v. weekly for 12 weeks followed by FEC (5-FU 500mg/m2 i.v.; Epirubicin 100 mg/m2 i.v. [or if given with Trastuzumab 75 mg/m2 i.v.]; Cyclophosphamide 500 mg/m2 i.v.) on Day 1 every 21 days for 4 cycles
20 | years-old | <= |
Not applicable |
Female
1) Histologically confirmed primary breast cancer
2) Clinical stage I-IIIB
3) Patients who scheduled for surgery after neoadjuvant chemotherapy
4) With estimative lesion
5) Age >= 20 years
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) ECOG performance status of 0 or 1
8) Required baseline laboratory parameters (within 14 days before registration)
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 10.0x104/mm3
Hb >= 9.0g/dL
AST <= 100 IU/L
ALT <= 100 IU/L
T-Bil <= 1.5mg/dL
Cre <= 1.5mg/dL
9) Written informed consent
1) Allergy of the medication
2) Synchronous or metachronous (within 5 years) double cancers
3) Serious complication
4) Contraindication to the study drugs
5) Peripheral neuropathy
6) Pregnancy, breast feeding or wish of future bearing
7) Patients considered inappropriate by the study investigator
50
1st name | |
Middle name | |
Last name | Shoji Oura |
Wakayama Medical University
Department of Thoracic and Cardiovascular Surgery
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
1st name | |
Middle name | |
Last name |
Wakayama Medical University
Department of Thoracic and Cardiovascular Surgery
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
073-441-0615
Wakayama Medical University
None
Self funding
Minami Wakayama Medical Center
Hashimoto Municipal Hospital
NO
2011 | Year | 07 | Month | 15 | Day |
Unpublished
Open public recruiting
2011 | Year | 06 | Month | 17 | Day |
2011 | Year | 07 | Month | 01 | Day |
2015 | Year | 06 | Month | 01 | Day |
2011 | Year | 07 | Month | 15 | Day |
2011 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007073
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