Clinical Trials List
Protocol NumberMK-2870-011
NCT Number(ClinicalTrials.gov Identfier)NCT06841354
Active
2025-03-01 - 2032-12-31
Phase III
Recruiting5
ICD-10C50.911
Malignant neoplasm of unspecified site of right female breast
ICD-10C50.912
Malignant neoplasm of unspecified site of left female breast
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.9
Malignant neoplasm of female breast, unspecified
A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/08/21
Investigators and Locations
Co-Principal Investigator
- 王國鐘 Division of General Surgery
- Kuan-Der Lee Division of Hematology & Oncology
- ZHENG-WEI ZHOU Division of Hematology & Oncology
- HSIN-CHEN LIN Division of Hematology & Oncology
- 林慈恩 Division of General Surgery
- Huey-En Tzeng Division of Hematology & Oncology
- 楊捷儒 無
- 楊陽生 無
- 劉佳樺 無
- I-Chen Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- 沈士哲 Division of General Surgery
- Wen-Chi Shen Division of Hematology & Oncology
- 阮昱翔 Division of Radiology
- 周旭桓 Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- Wen-Ling Kuo Division of General Surgery
- Shin-Cheh Chen Division of General Surgery
- Mengting Peng Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
- Chan-Keng Yang Division of Hematology & Oncology
- Chun-Hsiu Liu
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- MING-YANG WANG Division of General Surgery
- 李佳真 Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- 林柏翰 Division of General Internal Medicine
- WEI-LI MA Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- 陳怡君 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 黃柏翔 Division of Hematology & Oncology
- 楊明翰 Division of Hematology & Oncology
- 羅喬 無
- 陳怡君 無
- 魏以宣 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
- Chun-Hui Lee Division of Hematology & Oncology
- Kuo-Ting Lee Division of General Surgery
- Shang-Hung Chen Division of Hematology & Oncology
- 黃怡菁
- 楊舜如
- Jui-Hung Tsai
- Zhu-Jun Loh
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Triple Negative Breast Neoplasms
Objectives
主要目的
- 針對所有受試者，由盲性獨立中央審查（BICR）根據實體腫瘤反應評估標準第1.1版（RECIST 1.1）評估，在PFS方面比較sac-TMT與TPC。
- 針對所有受試者，由BICR根據RECIST 1.1評估，在PFS方面比較sac-TMT加上pembrolizumab與TPC。
- 針對所有受試者，在OS方面比較sac-TMT與TPC。
次要目的
- 針對所有受試者，在OS方面比較sac-TMT加上pembrolizumab與TPC。
- 針對所有受試者，由BICR根據RECIST 1.1評估，在PFS方面比較sac-TMT加上pembrolizumab與sac-TMT。
- 針對所有受試者，由BICR根據RECIST 1.1評估，在客觀反應率（ORR）方面比較sac-TMT與TPC。
- 針對所有受試者，由BICR根據RECIST 1.1評估，在ORR方面比較sac-TMT加上pembrolizumab與TPC。
- 針對所有受試者，在OS方面比較sac-TMT加上pembrolizumab與sac-TMT。
- 針對所有受試者，由BICR根據RECIST 1.1評估，在反應持續時間（DOR）方面評估sac-TMT、sac-TMT加上pembrolizumab與TPC。
- 針對所有受試者，使用歐洲癌症研究和治療組織生活品質核心問卷30（EORTC QLQ-C30）比較sac-TMT與TPC在健康相關生活品質（HRQoL）從基期以來的平均變化。
- 針對所有受試者，使用EORTC QLQ-C30比較sac-TMT加上pembrolizumab與TPC在HRQoL從基期以來的平均變化。
- 評估sac-TMT、sac-TMT加上pembrolizumab與TPC的安全性和耐受性。
Test Drug
注射用凍晶粉末
注射劑
注射劑
Active Ingredient
MK-2870
Pembrolizumab (MK-3475)
Pembrolizumab (MK-3475)
Dosage Form
048
270
270
Dosage
200 mg
100mg/ 4mL
100mg/ 4mL
Endpoints
•PFS：從隨機分配至首次記錄的疾病惡化或因任何原因死亡的時間，以先發生者為準。
•OS：從隨機分配至因任何原因死亡的時間。
•OS：從隨機分配至因任何原因死亡的時間。
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
The main inclusion criteria include but are not limited to the following:
Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has breast cancer amenable to treatment with curative intent
Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
Has Grade ≥2 peripheral neuropathy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has skin only metastatic disease
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
History of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications
The main exclusion criteria include but are not limited to the following:
Has breast cancer amenable to treatment with curative intent
Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
Has Grade ≥2 peripheral neuropathy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has skin only metastatic disease
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
History of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications
The Estimated Number of Participants
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Taiwan
28 participants
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Global
1000 participants
