Unique ID issued by UMIN | UMIN000006288 |
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Receipt number | R000007435 |
Scientific Title | Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer |
Date of disclosure of the study information | 2011/09/05 |
Last modified on | 2014/01/29 08:02:45 |
Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer
Primary Chemotherapy with Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Phase II Study of Primary Chemotherapy with Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients with HER2 Positive Breast Cancer
Primary Chemotherapy with Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Japan |
Patients with HER2 positive operable breast cancer
Breast surgery |
Malignancy
NO
To evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
To evaluate the pathologic complete response rate
To evaluate the disease free survival
To evaluate the overall response rate
To evaluate the histological therapeutic effect
To assess breast conserving rate after preoperative chemotherapy
To assess the adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.
Anthracycline-based regimen (d1, q3w):
EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2)
AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2)
FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)
Nab-paclitaxel 260mg/m2 (d1, q3w)
Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.
20 | years-old | <= |
70 | years-old | >= |
Female
1. Histologically confirmed invasive breast cancer
2. T1c-3 N0-2a
3. Confirmed of hormonal receptor status
4. HER2 positive confirmed by IHC 3+ or FISH+
5. LVEF > 50% by echocardiogram or MUGA
6. Adequate EKG
7. No prior treatment for breast cancer
8. PS 0-1
9. Required baseline laboratory data
WBC > 4,000/mm3 and Neut > 2,000/mm3
PLT > 100,000/mm3
Hb > 9.0g/dl
AST and ALT < ULNx2.5
T-Bil < 1.5mg/dl
Serum creatinin < 1.5mg/dl
10. Written informed consent
1. With history of hypersensitivity reaction for important drug in this study
2. With history of invasive breast cancer
3. Bilateral invasive breast cancer
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
5. Positive for HBs antigen and with history of HVB
6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
7. With severe edema
8. With severe peripheral neuropathy
9. With severe psychiatric disorder
10. Pregnant or nursing women
11. Cases who physician judged improper to entry this trial
45
1st name | |
Middle name | |
Last name | Mitsuhiko Iwamoto |
Osaka Medical College Hospital
Breast and endocrine surgery
2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
072-683-1221
sur112@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Satoru Tanaka |
Osaka Medical College Hospital
Breast and endocrine surgery
2-7 Daigaku-machi, Takatsuki-city, Osaka 569-8686, Japan
072-683-1221
sur112@poh.osaka-med.ac.jp
Breast and endocrine surgery
Osaka Medical College Hospital
None
Self funding
NO
大阪医科大学附属病院(大阪府)
2011 | Year | 09 | Month | 05 | Day |
Unpublished
Completed
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 09 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2011 | Year | 09 | Month | 05 | Day |
2014 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007435
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