UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer
Acronym	KBCOG 12
Scientific Title	A phase II study of Paclitaxel combined with Bevacizumab in HER2 negative metastatic Breast Cancer
Scientific Title:Acronym	KBCOG 12
Region	Japan

Condition
Condition	metastatic Breast Cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of paclitaxel in combination with bevacizumab in metastatic breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Clinical benefit rate, Progression-free survival, Safety

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	paclitaxel 90mg/mm2, day 1, 8, 15 bevacizumab 10mg/kg, day 1, 15 Treatment is administered every 4 weeks until evidence of progression, unacceptable toxicity, patient refusal.
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	80 years-old >=
Gender	Female
Key inclusion criteria	1) Histologically confirmed primary breast cancer 2) Age>=20, <=80 3) ECOG PS: 0-1 4) Measurable lesion 5) Primary chemotherapy refractory 6) Without the symptomatic brain metastasis 7) Without paclitaxel for previous treatment (Eligible if paclitaxel are used in neo-adjuvant or adjuvant setting and completed more than 12 month before registration) 8) Required baseline laboratory parameters before registers: WBC : >= 3,000mm3 or neutrophil : >= 1,500mm3 Plt : >= 75,000mm3 Hb : >= 9.0g/dl AST <= 2.5 times ULN and ALT <= 2.5 times ULN (<=5.0 with liver metastasis) Serum creatinine <= ULN Normal EOG 9) Signed informed consent of the patient for the registration
Key exclusion criteria	1) Previously treated with bevacizumab 2) Primary chemotherapy refractory with Paclitaxel 3) The operation has been scheduled for the examination period 4) Uncontrollable hypertension 5) Symptomatic brain metastasis 6) Anaphylaxis against drugs used in protocol treatment 7) Uncontrollable ascites, pleural effusion 8) Active infection, Severe complications (abnormal electrocardiogram, heart failure, arrhythmia, thromboembolism, etc) 9) Severe infection or serious complications, such as hypoalimentation 10) Other active malignancies 11) Pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 12) Doctors decision for exclusion
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kishimoto
Organization	Meiwa Hospital
Division name	Department of breast and endocrine surgery
Zip code	6638186
Address	Kaminaruo-cho 4-31, Nishinomiya, Hyogo, 663-8186
TEL	0798-47-1767
Email	mm-kishi@hotmail.co.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Kishimoto
Organization	Meiwa Hospital
Division name	Department of breast and endocrine surgery
Zip code	6638186
Address	Kaminaruo-cho 4-31, Nishinomiya, Hyogo, 663-8186
TEL	0798-47-1767
Homepage URL
Email	mm-kishi@hotmail.co.jp

Sponsor
Institute	Kobe Breast Cancer Oncology Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization	Meiwa Hospital
Address	Nishinomiya city, Agenaruocho, 4-31
Tel	0795
Email	mm-kishi@hotmail.co.jp

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 06 Month 12 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	Terminated
Date of protocol fixation	2012 Year 04 Month 23 Day
Date of IRB	2012 Year 03 Month 31 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 06 Month 11 Day
Last modified on	2021 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009588