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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010755
Receipt No. R000012568
Scientific Title Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer
Date of disclosure of the study information 2013/05/17
Last modified on 2019/11/25

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Basic information
Public title Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer
Acronym PerSeUS-BC02
Scientific Title Observational study to examine the efficacy of bevacizumab and paclitaxel combination therapy that targets inoperable or recurrent breast cancer
Scientific Title:Acronym PerSeUS-BC02
Region
Japan

Condition
Condition inoperable or recurrent breast cancer
Classification by specialty
Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of bevacizumab and paclitaxel combination therapy in patients with inoperable or recurrence HER2 negative breast cancer within 1 regimen under actual conditions in domestic use.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Overall response rate, 1-year survival rate, 2-year survival rate, 3-year survival rate, Safety

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients who were histologically or cytologically diagnosed as breast cancer.
2. Inoperable or recurrent breast cancer patients.
3. Patients with age of 20 years or older at registration
4. HER2 negative (FISH negative or IHC 2+ or less) (need to check HER2 status by FISH if IHC score is 2+)
5. Expression of ER and PgR should be confirmed by immunohistochemical staining, etc.
6. ECOG preformance status (PS 0-2)
7. No sequential use after neoadjuvant/adjuvant chemotherapy.
8. Patients who previously treated with no more than one chemotherapy regimen for metastatic or inoperable recurrent breast cancer *Endocrine therapy not included.
9. Sufficient major organ functions (determined by the attending physician).
10. Agreed to receive the combination therapy with bevacizumab and paclitaxel
11. Written informed consent
12. Patients with brain metastasis are also feasible under strict observation. When brain complications occur, appropriate care should be performed.
Key exclusion criteria 1.Prior therapy with bevacizumab
2. Recurrence during adjuvant chemotherapy
3.History of hypersensitivity to the components of bevacizumab or paclitaxel
4.Women who are pregnant, lactating or declined contraception
5.Congestive heart failure, unstable angina, uncontrolled arrhythmia
6.Uncontrolled hypertension
7.Patients with ptoteinuria (>Grade2)
8.Arterial thromboembolism (stroke, myocardial infarction, etc.)
9.Venous thromboembolism (deep vein thrombosis, pulmonary embolism)
10.Gastrointestinal perforation or severe gastrointestinal fistula
11.Planned surgery within 4w prior to the study
12. nonhealing wound or fracture.
13.Patients considered ineligible by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshida
Middle name
Last name Kazuhiro Yoshida
Organization Gifu University Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code 501-1194
Address 1-1 Yanagido, Gifu City
TEL 058-230-6000
Email mfutamur@gifu-u.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Futamura
Organization Gifu University Graduate School of Medicine
Division name Breast and Molecular Oncology
Zip code 501-1194
Address 1-1 Yanagido, Gifu City
TEL 058-230-6000
Homepage URL
Email mfutamur@gifu-u.ac.jp

Sponsor
Institute PerSeUS:Perpetual Study estimated-by United Sections in Gifu
Institute
Department

Funding Source
Organization None
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 Gifu University
Address 1-1Yanagido Gifu
Tel 0582306000
Email mfutamur@gifu-u.ac.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
2013 Year 05 Month 17 Day

Related information
URL releasing protocol Not done
Publication of results Published

Result
URL related to results and publications 2017 JSCO meeting
Number of participants that the trial has enrolled 26
Results PFS (n=26 median ) 5.9M
Results date posted
2019 Year 11 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Unresectable, Locally advanced BC
over 20
HER2-,
Participant flow 25 of 26 cases were analized
Adverse events over G3

Peripheral neuropathy:5
HT:4
Liver damage:1
fatigue:1
skin necrosis:1
Outcome measures PFS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 06 Month 06 Day
Date of IRB
2006 Year 06 Month 06 Day
Anticipated trial start date
2012 Year 06 Month 06 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information add related study

Management information
Registered date
2013 Year 05 Month 17 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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