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JBCRG-C06 (SAFARI)
閉経後ER 陽性進⾏再発乳癌におけるフルベストラントの⾄適投与⽅法の検討
- 状況
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登録終了
- 目的
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国内使⽤実態下における、閉経後ER陽性進⾏再発乳癌における、フルベストラント投与症例を対象にして、臨床背景および治療歴がフルベストラントの治療成功期間（TTF）に与える影響をレトロスペクティブに評価する。また、副次的⽬的として、フルベストラントの治療（治療ラインやその効果など）が、進⾏再発乳癌の⽣命予後に与える影響を探索する。
- 対象
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- 評価項目
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主要解析: 臨床背景および治療歴がフルベストラントの治療成功期間（TTF）に与える影響 副次解析：臨床背景および治療歴がフルベストラント投与開始後の⽣存時間（OS）に与える影響
- 研究期間
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研究期間：研究承認後〜2019年4⽉30⽇まで
- 研究代表者
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川口 英俊 松山赤十字病院 乳腺外科
- 予定症例数
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1000例
- レジメン
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フルベストラント
- 研究資金
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アストラゼネカ株式会社
- 学会発表
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ER陽性/HER陰性進行再発乳癌に対する酢酸メドロキシプロゲステロンの有効性に関する検討 Retrospective study using database for the effectiveness of medroxyprogesterone acetate in patients with ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study
Retrospective study using database for the effectiveness of medroxyprogesterone acetate in patients with ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study
Influence of the adjuvant hormonal therapy on hormone sensitivity and survival outcomes in ER+ and HER2−advanced breast cancer: a subgroup analysis of the JBCRG-C06 Safari study
Outcomes of fulvestrant treatment in ER-positive HER2-positive advanced or metastatic breast cancer
Factors associated with prolonged OS in postmenopausal ER-positive advanced breast cancer patients
Outcomes of fulvestrant therapy among Japanese women with ER-positive HER2-positive advanced or metastatic breast cancer: A subgroup analysis of the Japan Breast Cancer Research Group(JBCRG)-C06 Safari study
Factors associated with prolonged post-recurrence survival in patients with postmenopausal estrogen receptor-positive breast cancer taking fulvestrant: A follow-up data of the JBCRG-C06 Safari study
Influence of the adjuvant hormonal therapy on hormone sensitivity and survival outcomes in ER+ and HER2−advanced breast cancer: a subgroup analysis of the JBCRG-C06 Safari study
閉経後ER陽性進行・再発乳癌におけるフルベストラントの至適投与方法の検討（JBCRG-C06: Safari）
Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer: A subgroup analysis (JBCRG-C06)
フルベストラントの長期奏効群を探索する多施設共同後方視コホート研究;JBCRG-C06 Safari試験
Search for appropriate treatment strategy using fulvestrant for postmenopausal ER-positive advanced or recurrent breast cancer patients in Japan (JBCRG-C06; Safari)
閉経後ER陽性進行再発乳癌におけるフルベストラントの至適投与方法の検討（JBCRG-C06:Safari試験）
- 論文発表
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Fulvestrant with or without anti-HER2 therapy in patients in a postmenopausal hormonal state and with ER-positive HER2-positive advanced or metastatic breast cancer: a subgroup analysis of data from the Safari study (JBCRG-C06)
Retrospective study on the effectiveness of medroxyprogesterone acetate in the treatment of ER-positive/HER2-negative postmenopausal advanced breast cancer: An additional analysis of the JBCRG-C06 Safari study
Factors associated with overall survival after recurrence in patients with ER-positive/HER2-negative breast cancer: An ad-hoc analysis of the JBCRG-C06 Safari study
Factors associated with prolonged overall survival in patients with postmenopausal estrogen receptor-positive advanced breast cancer using real-world data: a follow-up analysis of the JBCRG-C06 Safari study
Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with post-menopausal estrogen receptor-positive advanced breast cancer: a sub-group analysis of the JBCRG-C06 Safari study.
Effectiveness of Fulvestrant in Advanced or Metastatic Breast Cancer Patients in the Real World: A Retrospective Multi-center Cohort Study with 1072 Patients (JBCRG-C06; Safari)
- UMIN-ID
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UMIN000015168
- jRCT
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- 備考
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- 利益相反の開示
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