UMIN-CTR Clinical Trial
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane
- PhaseII -
Acronym
SBP-05: CARP trial
Clinical evaluation of avastin to patients relapsed after taxane
Scientific Title
Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane
- PhaseII -
Scientific Title:Acronym
SBP-05: CARP trial
Clinical evaluation of avastin to patients relapsed after taxane
Region
| Japan |
Condition
Condition
HER2 negative breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety by paclitaxel and bevacizumab for HER2 negative relapsed breast cancer who previously treated with taxane
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Progression free survival, Overall survival, Time to treatment failure, Clinical benefit rate, Efficacy analysis by taxane, Safety profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bavacizumab 10 mg/m2 and Paclitaxel 90 mg/m2
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
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+
Key exclusion criteria
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
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ohtani |
Organization
Hiroshima City Hospital
Division name
Breast surgery
Zip code
Address
7-33 Motomachi, Naka-ku, Hirosima city, 730-8518, Japan
TEL
082-221-2291
sho_ohtani@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taira Naruto |
Organization
Setouchi Breast Project Comprehensive Support Organization
Division name
Clinical trial committee
Zip code
Address
2-5-1, Shikata, Kita-ku, Okayama
TEL
086-235-7265
Homepage URL
http://setouchi-bp.com/
info@setouchi-bp.com
Sponsor or person
Institute
Setouchi Breast Project Comprehensive Support Organization
Institute
Department
Personal name
Funding Source
Organization
Setouchi Breast Project Comprehensive Support Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
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 |
