UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002738
Receipt number 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 13:47:15

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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 or person

Institute

Japan Breast Cancer Research Group (JBCRG)

Institute

Department

Personal name



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

Value
https://center6.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