Unique ID issued by UMIN | UMIN000002738 |
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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 |
Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
JBCRG-C02
Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
JBCRG-C02
Japan |
Breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
Investigate efficacy and safety of trastuzumab therapy in breast cancer patients who relapsed after treatment with trastuzumab as an adjuvant therapy.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Progression-free survival; PFS
Response rate, overall survival, safety
Observational
Not applicable |
Not applicable |
Female
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
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.
100
1st name | Hiroyasu |
Middle name | |
Last name | Yamashiro |
JBCRG (Japan Breast Cancer Research Group)
Graduate School of Medicine, Kyoto University,
606-8507
54 Kawara-cho Shogoin,
075-751-3660
yamashiro.bcs@gmail.com
1st name | Katsumasa |
Middle name | |
Last name | Kuroi |
Japan Breast Cancer Research Group (JBCRG)
Head Office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
03-6264-8873
http://www.jbcrg.jp/clinicaltrials/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Japan Breast Cancer Research Group (JBCRG)
Self funding
N/A
N/A
N/A
N/A
NO
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)
2009 | Year | 11 | Month | 11 | Day |
Published
https://doi.org/10.1177/1178223418786243
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)
Completed
2009 | Year | 07 | Month | 03 | Day |
2009 | Year | 07 | Month | 03 | Day |
2009 | Year | 07 | Month | 03 | Day |
2014 | Year | 06 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 06 | Day |
2016 | Year | 11 | Month | 01 | Day |
Investigate efficacy and safety of trastuzumab therapy in breast cancer patients who relapsed after treatment with trastuzumab as an adjuvant therapy.
2009 | Year | 11 | Month | 10 | Day |
2019 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002521
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