JP2020517739A - リンパ節陽性の初期ホルモン受容体陽性かつヒト上皮成長因子受容体2陰性乳癌の補助治療のための内分泌療法とアベマシクリブとの組み合わせ - Google Patents
リンパ節陽性の初期ホルモン受容体陽性かつヒト上皮成長因子受容体2陰性乳癌の補助治療のための内分泌療法とアベマシクリブとの組み合わせ Download PDFInfo
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Abstract
Description
高リスク、リンパ節陽性の初期ホルモン受容体陽性かつヒト上皮受容体2陰性乳癌患者における標準補助内分泌療法と組み合わせたアベマシクリブと標準補助内分泌療法単独との無作為化非盲検第3相試験
本試験の第1の目的は、STEEPシステムによって定義されるように、アベマシクリブ150mg1日2回+補助内分泌療法と補助内分泌療法単独に対するHR+かつHER2−初期乳癌患者に対して、侵襲性疾患のない生存(IDFS)の点で、有効性を評価することとする。
本試験の第2の目的は、
・Ki67係数が20%以上のHR+かつHER2−初期乳癌患者に対するIDFSの点での有効性を評価すること(中央実験室によるコホート1とコホート2の両方)、
・遠隔再発のない生存(DRFS)および全生存(OS)の点で、アベマシクリブ+補助内分泌療法と補助内分泌療法単独との有効性を査定すること、
・補助内分泌療法単独と比較したアベマシクリブ+補助的内分泌療法の安全性特性を評価すること、
・アベマシクリブ曝露と臨床的(有効性および安全性)結果との関連性を査定すること、
・全身レベルの腫瘍学および乳癌の自己申告による健康関連の生活の質(Functional Assessment of Cancer Therapy(FACT)−Breast 37項目アンケート)、内分泌療法特異的症状(Functional Assessment of Cancer Therapy−Endocrine Symptoms(第4版)(FACT−ES)19項目下位尺度および2 Functional Assessment of Chronic Illness Therapy Item Library (FACIT)(第2版)を基にした認知症状の項目、ならびに3FACITを基にした膀胱症状についての項目)、ならびにアベマシクリブおよび/または内分泌療法の間に経験した疲労(FACIT−Fatigue 13項目下位尺度)の点で、アベマシクリブ+補助内分泌療法対補助内分泌療法単独を査定すること、ならびに
・健康状態を査定して、EuroQolの5次元5段階アンケートを使用して、健康経済査定についての決定モデルを通知することである。
Claims (16)
- リンパ節陽性の初期HR+かつHER2−乳癌とすでに診断され、前記乳癌が切除された患者へ補助治療を提供する方法であって、有効量の内分泌療法を有効量のアベマシクリブまたはその薬学的に許容される塩と組み合わせて、遠隔再発のない生存を延ばすのに十分な期間、投与することを含む、方法。
- 前記内分泌療法がタモキシフェンまたはその薬学的に許容される塩である、請求項1に記載の方法。
- 前記内分泌療法がレトロゾールである、請求項1に記載の方法。
- 前記内分泌療法がアナストロゾールである、請求項1に記載の方法。
- 前記内分泌療法がエキセメスタンである、請求項1に記載の方法。
- 前記アベマシクリブまたは前記その塩が、150mgで1日2回投与される、請求項1〜5のいずれか1項に記載の方法。
- 前記アベマシクリブまたは前記その塩が、100mgで1日2回投与される、請求項1〜5のいずれか1項に記載の方法。
- リンパ節陽性の初期HR+かつHER2−乳癌とすでに診断され、前記乳癌が切除された患者へ補助治療を提供する上で同時、別個、または連続して使用するための、治療有効量のアベマシクリブまたはその薬学的に許容される塩と内分泌療法とを含む組み合わせであって、前記アベマシクリブまたは前記その塩と前記内分泌療法との投与が遠隔再発のない生存を延ばすのに十分な期間である、組み合わせ。
- リンパ節陽性の初期HR+かつHER2−乳癌とすでに診断され、前記乳癌が切除された患者へ補助治療を提供する上で治療有効量の内分泌療法と同時、別個、または連続した組み合わせで使用するための、治療有効量のアベマシクリブまたはその薬学的に許容される塩であって、前記アベマシクリブまたは前記その塩と前記内分泌療法との投与が遠隔再発のない生存を延ばすのに十分な期間である、治療有効量のアベマシクリブまたはその薬学的に許容される塩。
- リンパ節陽性の初期HR+かつHER2−乳癌とすでに診断され、前記乳癌が切除された患者へ補助治療を提供する上で治療有効量のアベマシクリブまたはその薬学的に許容される塩と同時、別個、または連続した組み合わせで使用するための、治療有効量の内分泌療法であって、前記アベマシクリブまたは前記その塩と前記内分泌療法との投与が遠隔再発のない生存を延ばすのに十分な期間である、治療有効量の内分泌療法。
- 前記内分泌療法がタモキシフェンまたはその薬学的に許容される塩である、請求項8〜10のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
- 前記内分泌療法がレトロゾールである、請求項8〜10のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
- 前記内分泌療法がアナストロゾールである、請求項8〜10のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
- 前記内分泌療法がエキセメスタンである、請求項8〜10のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
- 前記アベマシクリブまたは前記その塩が150mgで1日2回投与される、請求項8〜14のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
- 前記アベマシクリブまたは前記その塩が、100mgで1日2回投与される、請求項8〜14のいずれか1項に記載の組み合わせ、アベマシクリブもしくはその塩、または内分泌療法。
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JP2021130437A Active JP7376540B2 (ja) | 2017-05-02 | 2021-08-10 | リンパ節陽性の初期ホルモン受容体陽性かつヒト上皮成長因子受容体2陰性乳癌の補助治療のための内分泌療法とアベマシクリブとの組み合わせ |
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Non-Patent Citations (3)
Title |
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CANCER TREATMENT REVIEWS, vol. 45, JPN6020030159, 2016, pages 129 - 138, ISSN: 0004484990 * |
COLUMBUS, GINA, "EXPERT DISCUSSES ABEMACICLIB PLUS ANASTRAZOLE TRIAL IN HR+/HER2- BREAST CANCER", DE, JPN6020030158, ISSN: 0004484989 * |
CURR. TREAT. OPTIONS IN ONCOL., vol. 18:6, JPN6020030160, 2017, pages 1 - 16, ISSN: 0004484991 * |
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US20200054634A1 (en) | 2020-02-20 |
JP7376540B2 (ja) | 2023-11-08 |
WO2018204138A1 (en) | 2018-11-08 |
CN110545803A (zh) | 2019-12-06 |
US20210393630A1 (en) | 2021-12-23 |
EP3618820A1 (en) | 2020-03-11 |
JP2021181470A (ja) | 2021-11-25 |
CN115624552A (zh) | 2023-01-20 |
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