Unique ID issued by UMIN | UMIN000015168 |
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Receipt number | R000017287 |
Scientific Title | Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer |
Date of disclosure of the study information | 2014/09/16 |
Last modified on | 2021/08/06 08:24:51 |
Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
JBCRG-C06
Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
JBCRG-C06
Japan |
Patients with postmenopausal ER-positive advanced recurrent breast cancer
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
NO
The purpose of this study is to retrospectively evaluate effects of subject's clinical background and prior therapies on the treatment time with Fulvestrant(TTF), in patients with postmenopousal ER-positive advanced recurrent breast cancer receiving Fulvestrant in clinical setting in Japan. Also this study is to explore the impact on prognosis for advanced recurrent breast cancer receiving Fulvestrant as a secondary analysis.
In the explanatory analysis study, JBCRG-C06-A1 (MPA analysis), using the data accumulated in C06, the TTF (treatment success period) of MPA is clarified as real world data, and factors affecting TTF in patients using MPA in the third and subsequent treatments are investigated.
Efficacy
Confirmatory
Not applicable
Effects of clinical background and prior therapies on the treatment time with Fulvestrant (TTF)
Secondary analysis
1.Effects of clinical background and prior therapies on overall survival (OS) after start of Fulvestrant
2.Descriptive statistics of treatment
3.Summary of therapies administered to subjects with long survival
In the explanatory analysis study JBCRG-C06-A1 (MPA analysis), the treatment success period of MPA by treatment line (TTF), the number of endocrine therapy treatment lines for progression recurrence of MPA, and patient factors for TTF of MPA are evaluated.
Observational
Not applicable |
Not applicable |
Female
1) Patients with postmenopausal ER-positive advanced recurrent breast cancer after prior hormone therapy
2) Register the patients that start to use Fulvestrant between November, 2011 (after release of Fulvestrant) and December 31, 2014 in a real clinical treatment
1)Patients not agree with this study
1000
1st name | C061)Hidetoshi 2)Shinji C06-A11)Hidetoshi 2)Yutaka |
Middle name | |
Last name | JBCRG-C06 1)Kawaguchi 2)Ohno JBCRG-C06-A1 1)Kawaguchi 2)Yamamoto |
JBCRG-C06 1) Matsuyama Red Cross Hospital
2) The Cancer Institute Hospital Of JFCR
JBCRG-C06-A1 1) Matsuyama Red Cross Hospital 2) Kumamoto University, Graduate School of Medical Sciences
JBCRG-C06 1) Department of breast surgery 2) Breast Oncology Center JBCRG-C06-A1 1) Department of breast surgery 2) Department of breast and endocrine surgery
790-8524
1) 1 Bunkyo-cho , Matsuyama-shi, Ehime Japan
089-924-1111
hkawaguchi@matsuyama.jrc.or.jp
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Head office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
03-6264-8873
https://jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group(JBCRG)
AstraZeneca K.K.(JBCRG-C06)
Profit organization
Department of Breast and Endocrine Surgery, Graduate School of Life Sciences, Kumamoto University (JBCRG-C06,JBCRG-C06-A1)
N/A
N/A
N/A
N/A
NO
松山赤十字病院(愛媛県)、国立病院機構 九州がんセンター(福岡県)、弘前市立病院(青森県)、新潟県立がんセンター新潟病院(新潟県)、久留米総合病院(福岡県)、広島市民病院(広島県)、愛知県がんセンター中央病院(愛知県)、相良病院(鹿児島県)、北海道大学病院(北海道)、群馬県立がんセンター(群馬県)、昭和大学病院(東京都)、四国がんセンター(愛媛県)、北九州市立医療センター(福岡県)、がん研究会有明病院(東京都)、虎の門病院(東京都)、熊本大学医学部附属病院(熊本県)
2014 | Year | 09 | Month | 16 | Day |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Published
https://doi.org/10.1080/03007995.2017.1400426
1072
1031 patients (96.2%) were evaluable for efficacy. F500 was administered as 1st-line treatment in 2.0%, 2nd-line in 22.7%, 3rd-line in 26.7%, and >=4th-line in 48.6% patients. Median TTF was 5.4 months. Multivariate analysis found that earlier F500 use (1st and 2nd vs. 3rd vs.>=4th line; P<0.001), longer period from AMBC diagnosis to F500 use (>=3 vs.<3 years; P<.001), and no prior palliative chemotherapy administered for unresectable or MBC (no vs. yes; P<.001) was associated with significantly longer TTF.
2021 | Year | 08 | Month | 06 | Day |
2017 | Year | 11 | Month | 03 | Day |
Postmenopausal patients with ER-positive advanced recurrent breast cancer
1072 patients were registered that started to use Fulvestrant between November,2011 (after release of Fulvestrant) and December 31, 2014 in a real clinical treatment.
Three patients (0.3%) experienced grade 3 (CTCAE v.1.1) AEs including injection site infection (n = 1), lower-extremity peripheral neuropathy (n = 1).
The endpoint of this study was to evaluate the effect of clinical background and treatment line of F500 on TTF using multivariate analysis.
Main results already published
2014 | Year | 07 | Month | 30 | Day |
2013 | Year | 08 | Month | 08 | Day |
2014 | Year | 10 | Month | 01 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
This study is a retrospective observational study to investigate clinical experience of Fulvestrant. The study does not involve study-specific intervention such as treatments or tests because it is designed as an observational study. Instead, data obtained from daily practice is surveyed. Treatment method is selected for each subject by the attending physician and the subject herself.
2014 | Year | 09 | Month | 16 | Day |
2021 | Year | 08 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017287
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