Unique ID issued by UMIN | UMIN000035869 |
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Receipt number | R000040850 |
Scientific Title | Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer |
Date of disclosure of the study information | 2019/04/01 |
Last modified on | 2019/02/13 19:23:24 |
Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Combination therapy of nab-Paclitaxel+Pertuzumab+Trastuzumab
Japan |
metastatic breast cancer
Breast surgery |
Malignancy
NO
Evaluation of safety and efficacy of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancer
Safety,Efficacy
time to treatment failure
safety(after the first cycle)
response rate (best effect)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Treatment with nab-Paclitaxel (260mg/m2, q3w), Pertuzumab (840mg followed by 420mg, q3w) and Trastuzumab (8mg/kg followed by 6mg/kg, q3w)
20 | years-old | <= |
75 | years-old | > |
Female
1.Histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.Primary or metastatic region is HER2 positive: either 3+ over-expression by IHC or positive by FISH
3.With or without evaluable lesion
4.Female between 20 and 75 years old
5.Baseline left ventricular ejection fraction (LVEF) is >50% measured by echocardiography or MUGA scan.
6.PS: 0-2 (ECOG)
7.Expected survival time more than 6 months
8.Signed written informed consent
1.Without previous chemotherapy
2.With brain metastasis with symptom
3.With active another cancer
4.With uncontrollable hypertension, angina pectoris, congestive heart failure, myocardial infection within 6 months, arrhythmia that need treat, valvular heart disease
5.With dyspnea at rest due to metastatic lung lesion
6.Insufficient organ function meeting following criteria
Neutrophil <1500/mm2
Platelet <100000/mm2
Hemoglobin <8.0g/dL
AST(GOT)>100IU/L (with liver function disorder by metastasis)
ALT (GPT) >100IU/L (with liver function disorder by metastasis)
Serum total bilirubin <2.0mg/dL
Serum creatinine >2.0mg/dL or 177umol/L
7.With uncontrollable systemic disease (cardiovascular/pulmonary/metabolic, protracted wound healing, ulcer and bone fracture)
8.With uncontrollable hypercalcemia even by Bisphosphonate or denosumab
9.Pregnant or nursing women
10.Infection or possible infection associated with clinical symptoms
11.With history of hypersensitivity reaction for paclitaxel, trastuzumab, and pertuzumab.
12.Cases who physician judged improper to entry this trial
30
1st name | |
Middle name | |
Last name | Akira Tangoku |
The University of Tokushima Graduate School
Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan
088-633-7143
tangoku@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | Masami Morimoto |
The University of Tokushima Graduate School
Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
3-18-15 Kuramoto-cho, Tokushima City, Tokushima, 770-8503, Japan
088-633-7143
twop8air@tokushima-u.ac.jp
The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience
Other
NO
2019 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 02 | Month | 15 | Day |
2019 | Year | 04 | Month | 01 | Day |
2019 | Year | 02 | Month | 13 | Day |
2019 | Year | 02 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040850
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