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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002738
Receipt No. R000002521
Scientific Title Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
Date of disclosure of the study information 2009/11/11
Last modified on 2019/09/05

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Basic information
Public title Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
Acronym JBCRG-C02
Scientific Title Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
Scientific Title:Acronym JBCRG-C02
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigate efficacy and safety of trastuzumab therapy in breast cancer patients who relapsed after treatment with trastuzumab as an adjuvant therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Progression-free survival; PFS
Key secondary outcomes Response rate, overall survival, 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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who meet ALL the following criteria are eligible:
(1)Agreed to receive trastuzumab for recurrent breast cancer
(2)Prior Registration into JBCRG C-01
(3)Must have received for at least 10 months of approved (neo) trastuzumab adjuvant therapy
(4)Have evaluable lesion
(5)Untreated for recurrence
(6)LVEF >50% within 28days prior to registration.
(7)Signed written informed consent
Key exclusion criteria Patients who meet ANY ONE of the following criteria are NOT eligible:
(1)History of hypersensitivity to trastuzumab
(2)Patients who are pregnant, lactating or with possibility of pregnancy
(3)Stage IV at the first diagnosis
(4)Patients with brain metastasis
(5)Patients who were decided ineligible to this study from an investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroyasu
Middle name
Last name Yamashiro
Organization JBCRG (Japan Breast Cancer Research Group)
Division name Graduate School of Medicine, Kyoto University,
Zip code 606-8507
Address 54 Kawara-cho Shogoin,
TEL 075-751-3660
Email yamashiro.bcs@gmail.com

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Head Office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
TEL 03-6264-8873
Homepage URL http://www.jbcrg.jp/clinicaltrials/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization Japan Breast Cancer Research Group (JBCRG)
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 N/A
Address N/A
Tel N/A
Email N/A

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 兵庫県立塚口病院(兵庫県)
朝日大学歯学部附属村上記念病院(岐阜県)
熊本市立熊本市民病院(熊本県)
東京都立駒込病院(東京都)
札幌ことに乳腺クリニック(北海道)
さいたま赤十字病院(埼玉県)
京都第一赤十字病院(京都府)
京都大学医学部附属病院(京都府)
広島市民病院(広島県)
千葉県がんセンター(千葉県)
愛知県がんセンター(愛知県)
りんくう総合医療センター(大阪府)
呉医療センター・中国がんセンター(広島県)
相良病院(鹿児島県)
神鋼病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1177/1178223418786243
Number of participants that the trial has enrolled
Results
Result
Thirty-four patients were registered between July 2009 and June 2012. The median follow-up time was 23.7 months (2-24 months).  
	The 1- and 2-year PFS rates were 46.9 (95% confidence interval (95% CI): 29.2-62.9%) and 29.8% (95% CI: 15.0-46.3%), respectively (median 10.6 months). The median PFS time for patients receiving trastuzumab combined with chemotherapy was 13.9 months. The 1-and 2-year overall survival rates were 93.9 (95% CI: 77.9-98.4%) and 84.8% (95% CI: 67.4-93.4%).  Trastuzumab-induced grade 3/4 adverse events were not observed. 

Conclusion
This study suggests that the PFS and OS in Japanese patients who relapsed after perioperative trastuzumab therapy were similar with those in previous reports. Differences in patient backgrounds and treatments must be considered when interpreting the results. Trastuzumab should be used combination with chemotherapy and/or hormonal therapy for retreatment. Retreatment with Trastuzumab is safe.
(UMIN000002738)

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 Completed
Date of protocol fixation
2009 Year 07 Month 03 Day
Date of IRB
2009 Year 07 Month 03 Day
Anticipated trial start date
2009 Year 07 Month 03 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 06 Day
Date analysis concluded
2016 Year 11 Month 01 Day

Other
Other related information Investigate efficacy and safety of trastuzumab therapy in breast cancer patients who relapsed after treatment with trastuzumab as an adjuvant therapy.

Management information
Registered date
2009 Year 11 Month 10 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002521

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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