Anastrozole
證據等級: L1 | 預測適應症: 6 個
## 藥師評估報告
Anastrozole：從停經後乳癌到女性乳腺癌
一句話總結
Anastrozole 原本用於治療停經後婦女晚期乳癌及輔助治療早期乳癌。 TxGNN 模型預測它可能對**女性乳腺癌 (female breast carcinoma)** 有效， 目前有 **50+ 個臨床試驗**和 **20 篇文獻**支持這個方向。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 停經後婦女晚期乳癌、荷爾蒙接受器陽性早期乳癌輔助治療 |
| 預測新適應症 | 女性乳腺癌、神經母細胞瘤、vertebral anomalies and variable endocrine and T-cell dysfunction、ganglioneuroblastoma (disease)、腹膜後腫瘤、單核細胞白血病 |
| TxGNN 預測分數 | 99.68% |
| 證據等級 | L1 |
| 台灣上市 | 有上市 |
| 許可證數 | 20 張 |
| 建議決策 | Already Approved (原適應症範圍內) |
預測適應症詳細分析
1. female breast carcinoma L1 99.68% 主要分析
為什麼這個預測合理？
Anastrozole 是第三代非類固醇芳香環酶抑制劑，其作用機轉：
- 抑制芳香環酶：選擇性抑制芳香環酶（CYP19），阻斷雄激素轉化為雌激素
- 降低雌激素濃度：可將停經後婦女血清雌激素濃度降低約80-90%
- 抑制腫瘤生長：對雌激素受體陽性乳癌，減少雌激素刺激可抑制腫瘤生長
預測適應症「女性乳腺癌」與原適應症高度重疊，此預測印證了模型對 anastrozole 在乳癌治療中角色的正確識別。
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT05700006 | N/A | ACTIVE_NOT_RECRUITING | 100 | An Observational Study of Women With Breast Cancer Examining the Effect of Endoc... |
| NCT02206984 | PHASE2 | COMPLETED | 201 | A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer |
| NCT00323479 | PHASE4 | COMPLETED | 114 | A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as... |
| NCT02730091 | PHASE3 | TERMINATED | 98 | A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aroma... |
| NCT02188550 | PHASE2 | UNKNOWN | 20 | Phase II Single Arm Trial With Combination of Everolimus and Letrozole in Treatm... |
| NCT00255463 | PHASE2 | COMPLETED | 185 | Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicen... |
| NCT03081234 | PHASE3 | WITHDRAWN | 0 | A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to ... |
| NCT02476786 | PHASE2 | RECRUITING | 50 | Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estroge... |
| NCT00573755 | PHASE2 | TERMINATED | 4 | Phase II Randomized Study of Sorafenib Compared to Placebo When Administered in ... |
| NCT04272801 | PHASE2 | ACTIVE_NOT_RECRUITING | 84 | Pre-Operative Window of Adjuvant Endocrine Therapy to Inform Radiation Therapy D... |
| NCT00287534 | PHASE2 | COMPLETED | 1059 | A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare th... |
| NCT03822468 | PHASE2 | COMPLETED | 376 | A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and... |
| NCT00555477 | PHASE2 | TERMINATED | 69 | Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-I... |
| NCT00784862 | PHASE3 | COMPLETED | 9358 | A Randomised, Double Blind Trial to Assess the Pharmacokinetics of Arimidex Alon... |
| NCT02095184 | NA | COMPLETED | 42 | GCC 1366: A Prospective Study of Neoadjuvant Non-Steroidal Aromatase Inhibitors ... |
| NCT01216176 | PHASE1, PHASE2 | COMPLETED | 71 | A Phase I Pharmacokinetic and Randomized Phase II Trial of Neoadjuvant Treatment... |
| NCT01896050 | N/A | COMPLETED | 115 | A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Canc... |
| NCT02823262 | NA | TERMINATED | 65 | A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older |
| NCT00186121 | PHASE2 | COMPLETED | 35 | A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor P... |
| NCT00555867 | N/A | TERMINATED | 4923 | A Randomised in Practice Evaluation of the Influence of Patient's Understanding ... |
| NCT01402193 | PHASE3 | UNKNOWN | 220 | A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Ra... |
| NCT06507618 | PHASE3 | RECRUITING | 354 | A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to In... |
| NCT06016738 | PHASE3 | RECRUITING | 510 | A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Car... |
| NCT01783444 | PHASE2 | COMPLETED | 309 | A Three-arm, Randomized, Open Label, Phase II Study of Everolimus in Combination... |
| NCT00562458 | N/A | COMPLETED | 200 | ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Thera... |
| NCT00543127 | PHASE3 | TERMINATED | 870 | Phase III Trial Comparing Efficacy and Tolerance of Fulvestrant for 3 Years (y) ... |
| NCT05501704 | PHASE2 | RECRUITING | 60 | ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast ... |
| NCT06492616 | PHASE3 | RECRUITING | 4220 | Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positiv... |
| NCT03778931 | PHASE3 | COMPLETED | 478 | Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ... |
| NCT00111241 | N/A | COMPLETED | 115 | Assessment of Knee Joint Articular Cartilage Volume Change, Bone Loss and Change... |
| NCT04088110 | PHASE2 | UNKNOWN | 77 | Pyrotinib Maleate Combined With Trastuzumab Plus Aromatase Inhibitor in the Firs... |
| NCT00641303 | NA | COMPLETED | 51 | A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of ... |
| NCT04236310 | PHASE2 | UNKNOWN | 37 | A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and T... |
| NCT07071038 | PHASE2 | NOT_YET_RECRUITING | 62 | The 'SWIVEL' Study (Switch Vs Effects Relief): Effectiveness of a Medication 'Sw... |
| NCT00508586 | PHASE1 | COMPLETED | 33 | A Phase 1b Study to Assess the Safety, Feasibility, Pharmacokinetics, and Activi... |
| NCT00784680 | PHASE3 | COMPLETED | 308 | A Randomised, Double-Blind, Parallel Group Trial to Assess Quality of Life With ... |
| NCT00661531 | PHASE2 | TERMINATED | 11 | A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Wom... |
| NCT00537771 | PHASE4 | COMPLETED | 384 | A Prospective, Randomized, Multicentre, Comparative and Open-label Study on Hepa... |
| NCT04852081 | N/A | UNKNOWN | 1000 | Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negat... |
| NCT03272477 | PHASE2 | COMPLETED | 257 | A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Co... |
| NCT00762294 | N/A | COMPLETED | 25 | Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral De... |
| NCT01016665 | NA | COMPLETED | 71 | Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Ter... |
| NCT04767594 | N/A | ACTIVE_NOT_RECRUITING | 1409 | PERFORM: An EPidEmiological, PRospective Cohort Study to Generate Real-world Evi... |
| NCT03078751 | PHASE2 | COMPLETED | 54 | An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ri... |
| NCT00570323 | PHASE2 | COMPLETED | 72 | A Phase II Trial of Neoadjuvant Arimidex With or Without Faslodex in Postmenopau... |
| NCT05837455 | PHASE2 | RECRUITING | 81 | NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy f... |
| NCT00398489 | PHASE2 | UNKNOWN | 94 | Evaluation of Response Rate to Pre-Operative Docetaxel + Herceptin Study Part A ... |
| NCT00405938 | PHASE2 | COMPLETED | 79 | A Phase II Trial of Open-Label Bevacizumab Administered With Anastrozole or Fulv... |
| NCT02441946 | PHASE2 | COMPLETED | 224 | neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 We... |
| NCT00143390 | PHASE3 | COMPLETED | 298 | A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastro... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 31839281 | 2020 | Article | Lancet (London, England) | Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of ... |
| 15639680 | 2005 | Article | Lancet (London, England) | Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after c... |
| 20923259 | 2010 | Article | Expert opinion on drug safety | Anastrozole. |
| 14687437 | 2003 | Article | Current medical research and o | Focus on anastrozole and breast cancer. |
| 28614542 | 2017 | Article | Revista da Associacao Medica B | Use of anastrozole in the chemoprevention and treatment of breast cancer: A lite... |
| 16034487 | 2005 | Article | Drugs of today (Barcelona, Spa | Anastrozole. |
| 26160683 | 2015 | Article | Maturitas | Testosterone and breast cancer prevention. |
| 30499075 | 2020 | Article | Pathology oncology research : | Endocrine Therapy for Ductal Carcinoma In Situ (DCIS) of the Breast with Breast ... |
| 24912489 | 2014 | Article | Oncotarget | Anastrozole and everolimus in advanced gynecologic and breast malignancies: acti... |
| 16761927 | 2006 | Article | Expert review of anticancer th | Anastrozole for breast cancer: recent advances and ongoing challenges. |
| 34048027 | 2021 | Article | Clinical pharmacology and ther | Interaction Between SNP Genotype and Efficacy of Anastrozole and Exemestane in E... |
| 32701512 | 2020 | Article | JCI insight | Pharmacogenomics of aromatase inhibitors in postmenopausal breast cancer and add... |
| 16439860 | 2006 | Article | Oncology | Role of anastrozole across the breast cancer continuum: from advanced to early d... |
| 19445563 | 2009 | Article | Expert opinion on pharmacother | Comparative review of anastrozole, letrozole and exemestane in the management of... |
| 12113022 | 2001 | Article | Expert review of anticancer th | Anastrozole: pharmacological and clinical profile in postmenopausal women with b... |
| 39275052 | 2024 | Article | Molecules (Basel, Switzerland) | Exploring Radioiodinated Anastrozole and Epirubicin as AKT1-Targeted Radiopharma... |
| 17033446 | 2006 | Article | European journal of gastroente | Anastrozole-induced hepatotoxicity. |
| 21885816 | 2011 | Article | Cancer prevention research (Ph | Changes in breast density and circulating estrogens in postmenopausal women rece... |
| 26686313 | 2016 | Article | Lancet (London, England) | Anastrozole versus tamoxifen for the prevention of locoregional and contralatera... |
| 32632513 | 2020 | Article | Breast cancer research and tre | Genetic and clinical predictors of arthralgia during letrozole or anastrozole th... |
2. neuroblastoma L5 99.53%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
3. vertebral anomalies and variable endocrine and T-cell dysfunction L5 99.42%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
4. ganglioneuroblastoma (disease) L5 99.41%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
5. retroperitoneal neoplasm L4 99.33%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 21403449 | 2011 | Article | Gan to kagaku ryoho. Cancer & | [A case of possible retroperitoneal metastasis of breast cancer successfully tre... |
6. monocytic leukemia L5 99.16%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
台灣上市資訊
| 許可證號 | 品名 | 劑型 | 許可證持有者 | 狀態 |
|---|---|---|---|---|
| 衛署藥輸字第022282號 | 安美達錠1毫克 | 膜衣錠 | 臺灣阿斯特捷利康 | 有效 |
| 衛署藥製字第047539號 | 安納柔膜衣錠 | 膜衣錠 | 台灣東洋藥品 | 有效 |
| 衛署藥製字第055555號 | 培力安諾妥膜衣錠 | 膜衣錠 | 培力藥品 | 有效 |
| 衛署藥製字第056730號 | 杏輝安娜斯柔膜衣錠 | 膜衣錠 | 杏輝藥品 | 有效 |
| 衛部藥輸字第026515號 | 安瑞特膜衣錠 | 膜衣錠 | 凱沛爾藥品 | 有效 |
細胞毒性
| 項目 | 內容 |
|---|---|
| 細胞毒性分類 | 非細胞毒性（荷爾蒙療法） |
| 骨髓抑制風險 | 極低 |
| 致吐性分級 | 極低 |
| 監測項目 | 骨密度、血脂、肝功能 |
| 處置防護 | 一般藥物處置即可 |
安全性考量
- 藥物交互作用：
- 與 Tamoxifen 併用會降低 anastrozole 血中濃度，不建議合併使用
- 與含雌激素製劑併用會降低療效
- 主要副作用：
- 骨質疏鬆、骨折風險增加
- 關節痛、肌肉痛（約50%患者）
- 潮紅、盜汗
- 血脂異常
- 禁忌症：
- 停經前婦女
- 懷孕及哺乳期
- 嚴重肝功能不全
藥物-食物交互作用 (DFI)
葡萄柚 🟢 Minor
- 影響：葡萄柚對 Anastrozole 影響較小
- 建議：無需特別限制
藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
心血管疾病 🟡 Moderate
- 應謹慎使用本藥物。
Hypercholesterolemia 🟡 Moderate
- 應謹慎使用本藥物。
肝臟疾病 🟡 Moderate
- 需定期監測。通常無需調整劑量。可能有嚴重不良反應。
骨質疏鬆症 🟡 Moderate
- 應謹慎使用本藥物。需定期監測。特別注意族群：老年人。
結論與下一步
決策：Already Approved (原適應症範圍內)
理由： 預測適應症「女性乳腺癌」實際上是原核准適應症的一般性描述。Anastrozole 已是停經後荷爾蒙受體陽性乳癌的標準治療藥物之一。大量臨床試驗（如 ATAC、IBIS-II）已證實其療效與安全性。
臨床建議：
- 限用於停經後婦女或卵巢功能抑制後的婦女
- 定期監測骨密度，必要時給予骨質保護劑
- 注意關節症狀的處理，以提升治療順從性
- 與 CDK4/6 抑制劑併用可進一步提升晚期乳癌療效
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引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Anastrozole老藥新用驗證報告. https://twtxgnn.yao.care/drugs/anastrozole/
BibTeX 格式：
@misc{twtxgnn_anastrozole,
title = {Anastrozole老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/anastrozole/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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