Unique ID issued by UMIN | UMIN000009582 |
---|---|
Receipt number | R000011244 |
Scientific Title | Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane - PhaseII - |
Date of disclosure of the study information | 2012/12/19 |
Last modified on | 2018/09/18 23:08:59 |
Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane
- PhaseII -
SBP-05: CARP trial
Clinical evaluation of avastin to patients relapsed after taxane
Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane
- PhaseII -
SBP-05: CARP trial
Clinical evaluation of avastin to patients relapsed after taxane
Japan |
HER2 negative breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
Evaluation of efficacy and safety by paclitaxel and bevacizumab for HER2 negative relapsed breast cancer who previously treated with taxane
Efficacy
Confirmatory
Pragmatic
Phase II
Objective response rate
Progression free survival, Overall survival, Time to treatment failure, Clinical benefit rate, Efficacy analysis by taxane, Safety profile
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bavacizumab 10 mg/m2 and Paclitaxel 90 mg/m2
20 | years-old | <= |
Not applicable |
Female
1) Signed written informed consent
2) Female >=20 years old
3) Histologically or cytologically confirmed breast cancer
4) Relapsed patients who have previously treated (neo)adjuvant treatment with taxane (paclitaxel, docetaxel and nab-paclitaxel) at any DFI
5) HER2 negative*
*FISH negative or IHC <=2+; IHC =2+ has to be tested by FISH for negative status
6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
7) Life expectancy of at least 3 months
8) With measurable lesion defined by RECIST version 1.1 with stimative diseases, excluding lesion received radiotherapy
9) No previous chemo therapy for metastatic or inoperable breast cancer, hormone therapy is acceptable
10) Sufficient function of main organ and bone marrow met the following criteria within 2 weeks from registration:
1.Neutrophil counts, 1,500/mm3 or over.
2.Platelet counts, 100,000/mm3 or over.
3.Total bilirubin, 1.5mg/dl or less.
4.AST and ALT, x 3 of upper limit of normal (ULN) or less.
5.Serum creatinin, x 1.5 of ULN or less.
6.Proteinuria <=1+
1) Prior therapy with bevacizumab
2) Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell derived products or other recombinant humanized antibodies
3) Symptomatic brain metastasis
4) Women who is pregnant, lactating or declined contraception
5) Patients with a non-healing wound or fracture
6) Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg)
7) Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study
8) Symptomatic congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry
9) Idiopathic pulmonary fibrosis, interstitial lung disease
10) Baseline left ventricular ejection fraction (LVEF) > 50% measured by echocardiography
11) Current or previous history (within 12 months) of symptomatic cerebrovascular disease
12) Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism
13) Current or previous history (within 12 months) of GI perforation
14) Synchronous or metachronous tumors with <5 years disease-free period
15) Patients ineligible to the study based on decision of attending physician or site principal investigators
33
1st name | |
Middle name | |
Last name | Shoichiro Ohtani |
Hiroshima City Hospital
Breast surgery
7-33 Motomachi, Naka-ku, Hirosima city, 730-8518, Japan
082-221-2291
sho_ohtani@hotmail.com
1st name | |
Middle name | |
Last name | Taira Naruto |
Setouchi Breast Project Comprehensive Support Organization
Clinical trial committee
2-5-1, Shikata, Kita-ku, Okayama
086-235-7265
http://setouchi-bp.com/
info@setouchi-bp.com
Setouchi Breast Project Comprehensive Support Organization
Setouchi Breast Project Comprehensive Support Organization
Self funding
NO
2012 | Year | 12 | Month | 19 | Day |
Unpublished
Completed
2012 | Year | 11 | Month | 26 | Day |
2012 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 19 | Day |
2018 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011244
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |