癌症專業教育

乳癌診療與藥物治療專業指引 完整臨床實務手冊

十六、三陰性轉移性乳癌之治療選擇 (5)

發布日期：2025-12-01 更新日期：2025-12-23

本章目錄
  1. 16-1. TNBC 診斷與一線治療篩選依據
  2. 16-2. 一線治療：PD-L1抑制劑的角色與療效
  3. 16-3. PARP抑制劑及鉑類化療在 BRCA1/2 突變 TNBC 中的應用
  4. 16-4. 新型 ADC 藥物：Sacituzumab Govitecan
  5. 16-5. TNBC 轉移性乳癌核心臨床試驗數據彙整
  6. 乳癌治療總結
  7. 附錄1 乳癌抗癌藥物總覽
  8. 1. Hormone (Endocrine) Therapies
  9. 2. CDK4/6 Inhibitors
  10. 3. PI3K / AKT / mTOR Pathway Inhibitors
  11. 4. HER2-Targeted Therapies
  12. 5. Antibody-Drug Conjugates (ADCs)
  13. 6. Immunotherapy & PARP Inhibitors
  14. 7. Chemotherapy (Cytotoxic)

TNBC（ER-、PR-、HER2-）是一種侵襲性強的乳癌亞型，缺乏荷爾蒙受體和 HER2 的靶點，因此治療主要依賴化療、免疫檢查點抑制劑、PARP 抑制劑和新型抗體藥物複合體（ADC）。

16-1. TNBC 診斷與一線治療篩選依據

在診斷 TNBC 時，必須進行兩項關鍵的生物標誌物篩查：

  • PD-L1 狀態（Combined Positive Score, CPS）： 用於評估免疫檢查點抑制劑（如 Pembrolizumab）的適用性。

  • Germline BRCA1/2 突變： 用於指導 PARP 抑制劑的應用。

16-2. 一線治療：PD-L1抑制劑的角色與療效

一張含有 文字, 螢幕擷取畫面, 字型, 數字 的圖片 AI 產生的內容可能不正確。

PD-L1 陽性（CPS ≥ 10）策略

對於 PD-L1 狀態為 CPS ≥10 的患者，無論其 Germline BRCA 狀態如何，一線治療的首選是 Pembrolizumab (Keytruda®) 聯合化療。

核心試驗依據與療效數據：KEYNOTE-355 試驗 (40)

KEYNOTE-355 是一項 III 期試驗，比較 Pembrolizumab 聯合化療（nab-paclitaxel, paclitaxel, 或 gemcitabine/carboplatin）與安慰劑聯合化療在局部復發不可切除或轉移性 TNBC 患者中的療效。

  • CPS ≥ 10 亞組 PFS： Pembrolizumab 組合顯著改善 PFS (9.7 個月 vs 5.6 個月)，HR: 0.65; p = 0.0012。

  • CPS ≥ 10 亞組 OS： 最終分析證實，Pembrolizumab 組合顯著延長 OS (23.0 個月 vs 16.1 個月)，HR: 0.73; p = 0.0185。

臨床決策點： 該試驗確立了免疫治療的地位，但其 OS 益處僅限於 PD-L1 CPS ≥ 10 的高表達患者。

PD-L1 陰性或低表達（CPS < 10）策略

對於 PD-L1 CPS < 10 的患者，如果不存在 Germline BRCA 突變，則應採用傳統的單藥化療作為一線治療。

16-3. PARP抑制劑及鉑類化療在 BRCA1/2 突變 TNBC 中的應用

對於具有 Germline BRCA1/2 突變且 HER2-陰性的 MBC 患者，PARP 抑制劑（Olaparib, Talazoparib）是優先於單藥化療或鉑類化療的選擇 。NCCN 指南將 Olaparib 或 Talazoparib 列為 Category 1 優先選項。

一張含有 文字, 螢幕擷取畫面, 字型, 數字 的圖片 AI 產生的內容可能不正確。Olaparib (Lynparza®)：OlympiAD 試驗 (37)

  • 試驗設計： 比較 Olaparib 與醫師選擇的化療 (PCC) 在 gBRCA 突變、HER2-陰性MBC 患者中的療效。

  • 結果： Olaparib 顯著改善 PFS (7.0 個月 vs 4.2 個月)，HR 0.58; p < 0.001。在未接受過化療的一線治療患者中，OS 益處建議更為顯著 (HR 0.51)。

  1. Talazoparib (Talzenna®)：EMBRACA 試驗 (38)

    • 結果： Talazoparib 顯著改善 PFS (8.6 個月 vs 5.6 個月)，HR 0.542; p < 0.0001。

  2. 毒性管理： 兩種 PARP 抑制劑的主要毒性是血液學毒性，包括貧血和中性粒細胞減少。

16-4. 新型 ADC 藥物：Sacituzumab Govitecan

Sacituzumab Govitecan (Trodelvy®, SG) 是一種靶向 Trop-2 抗原的 ADC，在 TNBC 的後線治療中發揮關鍵作用。

核心試驗依據與療效數據：ASCENT 試驗 (39)

ASCENT 第III 期試驗，比較 SG 與醫師選擇的單藥化療 (TPC) 在 ≥ 2 線 TNBC 患者中的療效。

  • 試驗收案族群： 適用於已接受至少 2 線化療的轉移性 TNBC 患者。

  • PFS (無腦轉移亞組)： SG 顯著延長 PFS (5.6 個月 vs 1.7 個月)，HR 0.39; p < 0.0001。

  • OS (無腦轉移亞組)： SG 顯著延長 OS (12.1 個月 vs 6.7 個月)，HR 0.48; p < 0.0001。

  • SG 的主要毒性包括中性粒細胞減少症（Grade ≥ 3 發生率 51%）和腹瀉。

16-5. TNBC 轉移性乳癌核心臨床試驗數據彙整

試驗名稱 標靶藥物/對照組 治療線數 選藥依據 中位 PFS(月) PFS HR 中位 OS (月) OS HR
KEYNOTE-355 (40) Pembrolizumab + Chemo vs Chemo 一線 PD-L1 CPS ≥ 10 9.7 vs 5.6 0.65 (P= 0.0012) 23.0 vs 16.1 0.73 (P= 0.0185)
OlympiAD (37) Olaparib vs standard therapy 1-2 線 gBRCA1/2 突變 7.0 vs 4.2 0.58 (P= <0.001) 19.3 vs 19.6 0.90 (NS)
ASCENT (39) Sacituzumab Govitecan ≥ 2 線 TNBC 5.6 vs 1.7 0.39 (P< 0.0001) 12.1 vs 6.7 0.48 (P <0.0001)

乳癌治療總結

乳癌基礎、分期與臨床表現

  • 乳癌的治療決策高度依賴病理分類與分子亞型。組織學上以浸潤性乳腺癌 (IDC) 最常見。臨床上依據 ER、PR、HER2 及 Ki-67 的表現分為四種亞型：Luminal A (預後佳，賀爾蒙治療為主)、Luminal B (可能需化療)、HER2 陽性 (具侵襲性，需標靶治療) 及三陰性乳癌 (TNBC，復發風險最高)。分期採用 TNM 系統，依據腫瘤大小、淋巴結轉移及遠處轉移分為 0-IV 期，第 I 期治癒率極高，第 IV 期則以延長存活為目標。臨床表現初期多為無痛腫塊，隨病程進展可能出現皮膚橘皮樣變化、乳頭凹陷或異常分泌物；若發生骨骼或肺部轉移，則伴隨相應器官的疼痛或呼吸困難。

早期乳癌治療策略與術前輔助化療 (Neoadjuvant Therapy) 決策

  • 早期乳癌 (Stage I-III) 的治療目標為治癒。局部治療包含手術 (保留乳房手術或乳房切除) 與術後放射線治療。對於局部進階 (Stage III)、TNBC 或 HER2+ 患者，術前輔助治療為首選策略，旨在縮小腫瘤以利手術，目標達到病理完全緩解 (pCR)。全身性療法包括 TNBC 的 Pembrolizumab 結合化療 ，及 HER2+ 的雙標靶治療。

術後輔助治療 (Adjuvant Therapy)：荷爾蒙、化學療法與 HER2 標靶治療

  • 在術後輔助化療決策上，針對 HR+/HER2- 淋巴結陰性患者，建議使用基因檢測，依據復發分數 (RS) 決定是否化療；淋巴結陽性但停經後的低風險患者，化療亦可能無額外效益。

  • 荷爾蒙受體陽性 (HR+) 患者需接受 5-10 年內分泌治療。停經前婦女以 Tamoxifen 為主，高風險者建議加上卵巢功能抑制 (OAS) 甚至合併芳香環轉化酶抑制劑 (AI)；停經後婦女則首選 AI。針對高復發風險的 HR+ 患者，術後可選擇 CDK4/6 抑制劑 Abemaciclib 以降低復發率。

  • 在 HER2 陽性早期乳癌方面，標準治療為化療合併 Trastuzumab 一年。對於高風險 (淋巴結陽性) 患者，建議加上 Pertuzumab 進行雙標靶輔助治療。若術前治療後仍有殘存病灶，則建議術後改用 ADC 藥物 T-DM1。

  • 三陰性乳癌方面，則建議術後繼續使用Pembrolizumab 9個療程。

轉移性乳癌 (Stage IV) 的精準治療：

  • 轉移性乳癌強調延長存活期與生活品質，治療策略依亞型而定。

  • HR+/HER2- 第一線標準治療為 CDK4/6 抑制劑 (如 Ribociclib) 合併內分泌治療；第二線後則依基因檢測 (ESR1, PIK3CA, AKT) 選擇標靶藥物，或針對 HER2-Low 患者使用 T-DXd。

  • HER2 陽性轉移性乳癌的第一線首選為 THP 雙標靶 (Trastuzumab+Pertuzumab) 與化療組合；第二線首選 T-DXd (Enhertu)，療效優於 T-DM1。

  • 三陰性乳癌 (TNBC) 若 PD-L1 陽性 (CPS≥10) 首選免疫治療 (Pembrolizumab) 合併化療；具 gBRCA 突變者優先使用 PARP 抑制劑；後線治療則可選用針對 Trop-2 的 ADC 藥物 (Sacituzumab Govitecan)。

附錄1 乳癌抗癌藥物總覽

1. Hormone (Endocrine) Therapies

主要用於 ER/PR 陽性癌症。常與其他標靶藥物（如 CDK4/6 抑制劑）合併使用

Drug Name Mechanism ER/PR+ HER2+ TNBC Setting Major Side Effects

Tamoxifen

(Nolvadex®)

 SERM (Modulator) ✓ Risk Reduction, Adjuvant, Metastatic Hot flashes, vaginal discharge/dryness, risk of blood clots, endometrial cancer risk.

Raloxifene

(Evista®)

 SERM ✓ Prevention only (High risk) Hot flashes, leg cramps, blood clots (lower uterine cancer risk than Tamoxifen).

Toremifene

(Fareston®)

 SERM ✓ Metastatic Hot flashes, sweating, nausea, QT prolongation.

Fulvestrant

(Faslodex®)

 SERD (Degrader) ✓ Adv/Metastatic Injection site pain, hot flashes, fatigue, nausea, liver enzyme elevation.

Elacestrant

(Orserdu®)

 Oral SERD ✓ Adv/Metastatic (ESR1-mutated) Nausea, fatigue, vomiting, decreased appetite, joint pain, cholesterol changes.

Anastrozole

(Arimidex®)

Letrozole

(Femara®)

Exemestane

(Aromasin®)

 Aromatase Inhibitors (AIs) ✓ Adjuvant, Neoadjuvant, Metastatic Joint/muscle pain (arthralgia), bone thinning (osteoporosis), hot flashes, fatigue.

Goserelin

(Zoladex®)

Leuprolide (Eligard®)

 Ovarian Suppression (LHRH Agonists) ✓ Adjuvant, Metastatic (Premenopausal) Hot flashes, loss of libido, vaginal dryness, mood changes, bone density loss.

2. CDK4/6 Inhibitors

與荷爾蒙療法合併使用於 HR 陽性（荷爾蒙受體陽性）乳癌，以停止細胞分裂。

Drug Name Mechanism ER/PR+ HER2+ TNBC Setting Major Side Effects

Abemaciclib

(Verzenio®)

 CDK4/6 Inhibitor ✓ Adjuvant (High Risk), Metastatic Diarrhea (very common), fatigue, neutropenia, liver enzyme elevation, blood clots.

Ribociclib

(Kisqali®)

 CDK4/6 Inhibitor ✓ Adjuvant (Stg II/III), Metastatic QT prolongation (heart rhythm), neutropenia, liver enzyme elevation.

Palbociclib

(Ibrance®)

 CDK4/6 Inhibitor ✓ Metastatic Neutropenia (low white blood cells), fatigue, infections, hair thinning.

3. PI3K / AKT / mTOR Pathway Inhibitors

用於荷爾蒙治療後，疾病仍惡化時所使用的二線標靶療法。

Drug Name Mechanism HR+ HER2+ TNBC Setting Major Side Effects

Alpelisib

(Piqray®)

 PI3K Inhibitor ✓ Metastatic (PIK3CA-mutated) Hyperglycemia (high blood sugar), severe rash, diarrhea, fatigue.

Inavolisib

(Itovebi®)

 PI3K Inhibitor ✓ Metastatic (PIK3CA-mutated) Hyperglycemia, diarrhea, rash, stomatitis (mouth sores).

Capivasertib

(Truqap®)

 AKT Inhibitor ✓ Metastatic (AKT-pathway mutated) Diarrhea, rash, hyperglycemia.

Everolimus

(Afinitor®)

 mTOR Inhibitor ✓ Adv/Metastatic Mouth sores (stomatitis), rash, fatigue, pneumonitis (lung inflammation), hyperglycemia.

4. HER2-Targeted Therapies

專門針對 HER2 蛋白過度表現的癌症。

Drug Name Mechanism HR+ HER2+ TNBC Setting Major Side Effects

Trastuzumab

(Herceptin®)

 Monoclonal Antibody (If HER2+) ✓ Neoadjuvant, Adjuvant, Metastatic Cardiomyopathy (heart weakening), infusion reactions.

Pertuzumab

(Perjeta®)

 Monoclonal Antibody (If HER2+) ✓ Neoadjuvant, Adjuvant, Metastatic Diarrhea, hair loss, nausea, fatigue, heart weakening (rare).

Margetuximab

(Margenza®)

 Monoclonal Antibody (If HER2+) ✓ Metastatic Infusion reactions, fatigue, nausea, diarrhea.
Phesgo® Fixed-dose Combo (If HER2+) ✓ Neoadjuvant, Adjuvant, Metastatic Injection site reactions; similar to Trastuzumab/Pertuzumab.

Tucatinib

(Tukysa®)

 Tyrosine Kinase Inhibitor (If HER2+) ✓ Metastatic (inc. Brain Mets) Diarrhea (can be severe), hand-foot syndrome, liver enzyme elevation.

Neratinib

(Nerlynx®)

 Tyrosine Kinase Inhibitor (If HER2+) ✓ Extended Adjuvant, Metastatic Severe Diarrhea, nausea, vomiting, fatigue.

Lapatinib

(Tykerb®)

 Tyrosine Kinase Inhibitor (If HER2+) ✓ Metastatic Diarrhea, hand-foot syndrome, rash, liver toxicity.

5. Antibody-Drug Conjugates (ADCs)

抗體藥物複合體利用抗體將化療藥物直接遞送至癌細胞。

Drug Name Mechanism HR+ HER2+ TNBC Setting Major Side Effects

Trastuzumab Deruxtecan (T-DXd)

(Enhertu®)

 Anti-HER2 + Topo I Inh. ✓ (HER2-Low) ✓ ✓ (HER2-Low) Metastatic Interstitial Lung Disease (ILD) (can be fatal), nausea, neutropenia, hair loss.

Trastuzumab Emtansine (T-DM1)

(Kadcyla®)

 Anti-HER2 + Microtubule Inh. ✓ Adjuvant (residual disease), Metastatic Platelet count drop (thrombocytopenia), liver enzyme elevation, neuropathy.

Sacituzumab Govitecan

(Trodelvy®)

 Anti-TROP2 + Topo I Inh. ✓ ✓ Metastatic Severe neutropenia, severe diarrhea, nausea, hair loss.

Datopotamab Deruxtecan

(Datroway®)

 Anti-TROP2 + Topo I Inh. ✓ Metastatic Stomatitis (mouth sores), nausea, fatigue, dry eye; lower rates of diarrhea/neutropenia than others.

6. Immunotherapy & PARP Inhibitors

Drug Name Mechanism HR+ HER2+ TNBC Setting Major Side Effects

Pembrolizumab

(Keytruda®)

 PD-1 Inhibitor (Immune Checkpoint) ✓ Neoadjuvant (High Risk), Metastatic (PD-L1+) Immune-mediated events (colitis, pneumonitis, thyroid/adrenal issues), fatigue, rash.

Olaparib

(Lynparza®)

 PARP Inhibitor ✓ (BRCA+) ✓ (BRCA+) Adjuvant, Metastatic Anemia, nausea, fatigue, vomiting, small risk of blood cancers (MDS/AML).

Talazoparib

(Talzenna®)

 PARP Inhibitor ✓ (BRCA+) ✓ (BRCA+) Metastatic Anemia (often requires transfusion), fatigue, nausea.

7. Chemotherapy (Cytotoxic)

適用於所有亞型，通常是在腫瘤負荷（Tumor burden）高或疾病具侵襲性時使用。

Drug Name Class HR+ HER2+ TNBC Setting Major Side Effects

Paclitaxel

(Taxol®)

Docetaxel

(Taxotere®)

 Taxanes ✓ ✓ ✓ Neo/Adjuvant, Metastatic Neuropathy (numbness/tingling), total hair loss, allergic reactions, fluid retention (Docetaxel).

Doxorubicin

(Doxo®)

Epirubicin

(Ellence®)

 Anthracyclines ✓ ✓ ✓ Neo/Adjuvant, Metastatic Cardiotoxicity (heart damage), hair loss, nausea, risk of leukemia.

Carboplatin

(Paraplatin ®)
Cisplatin

(Cisplatin®)

 Platinums ✓ Neoadjuvant, Metastatic Bone marrow suppression, neuropathy, kidney damage (Cisplatin), nausea.

Capecitabine

(Xeloda®)

 Antimetabolite (Oral) ✓ ✓ ✓ Adjuvant (residual TNBC), Metastatic Hand-Foot Syndrome (peeling/painful palms & soles), diarrhea.
Cyclophosphamide (Endoxan®) Alkylating Agent ✓ ✓ ✓ Neo/Adjuvant, Metastatic Nausea, hair loss, bladder irritation (cystitis), fertility loss.

Eribulin

(Halaven®)

 Microtubule Inhibitor ✓ ✓ ✓ Metastatic Neuropathy, neutropenia, hair loss.

Gemcitabine

(Gemzae®)

 Antimetabolite ✓ ✓ ✓ Metastatic Platelet drop, flu-like symptoms, liver enzyme elevation.

Vinorelbine

(Navelbine®)

 Microtubule Inhibitor ✓ ✓ ✓ Metastatic Constipation, neuropathy, venous irritation, neutropenia.

作者: 傅彥崴藥師編輯。

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