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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012568