UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Weekly paclitaxel in combination with bevacizumab in patient with HER2 nagative breast cancer who were previously treated with taxane - PhaseII -
Title of the study (Brief title)	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	Shoichiro Ohtani
Organization	Hiroshima City Hospital
Division name	Breast surgery
Address	7-33 Motomachi, Naka-ku, Hirosima city, 730-8518, Japan
TEL	082-221-2291
Email	sho_ohtani@hotmail.com

Public contact
Name of contact person	Taira Naruto
Organization	Setouchi Breast Project Comprehensive Support Organization
Division name	Clinical trial committee
Address	2-5-1, Shikata, Kita-ku, Okayama
TEL	086-235-7265
Homepage URL	http://setouchi-bp.com/
Email	info@setouchi-bp.com

Sponsor
Institute	Setouchi Breast Project Comprehensive Support Organization
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011244