UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010755 |
|---|---|
| Receipt number | 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 19:11:46 |
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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
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
mfutamur@gifu-u.ac.jp
Sponsor or person
Institute
PerSeUS:Perpetual Study estimated-by United Sections in Gifu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012568
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
