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)
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 周旭桓 Division of General Surgery
- Mengting Peng Division of Hematology & Oncology
- 阮昱翔 Division of Radiology
- Wen-Chi Shen 無
- Wen-Ling Kuo 無
- Chan-Keng Yang Division of Hematology & Oncology
- 沈士哲 無
- Yung-Chang Lin Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
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
- 楊舜如 無
- 黃怡菁 無
- Shang-Hung Chen 無
- Zhu-Jun Loh 無
- Kuo-Ting Lee 無
- Jui-Hung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chih-Chiang Hung
Co-Principal Investigator
- 王國鐘 Division of General Surgery
- 林慈恩 Division of General Surgery
- 劉佳樺 無
- HSIN-CHEN LIN Division of Hematology & Oncology
- 楊陽生 無
- ZHENG-WEI ZHOU 無
- 楊捷儒 無
- Kuan-Der Lee Division of Hematology & Oncology
- Huey-En Tzeng 無
- I-Chen Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Triple Negative Breast Neoplasms
Objectives
Primary Objectives:
- Compare PFS (progression-free survival) between sac-TMT and TPC, assessed by a blinded independent central review (BICR) according to RECIST version 1.1 (Solid Tumor Response Assessment Criteria, Version 1.1) for all participants.
- Compare PFS (progression-free survival) between sac-TMT plus pembrolizumab and TPC, assessed by BICR according to RECIST 1.1, for all participants.
- Compare OS (overall survival) between sac-TMT and TPC, for all participants.
Secondary Objectives:
- Compare OS (overall survival) between sac-TMT plus pembrolizumab and TPC, for all participants.
- Compare PFS (progression-free survival) between sac-TMT plus pembrolizumab and sac-TMT, assessed by BICR according to RECIST 1.1, for all participants.
- Compare Objective Response Rate (ORR) between sac-TMT and TPC, assessed by BICR according to RECIST 1.1, for all participants.
- For all participants, BICR assessed ORR according to RECIST 1.1, comparing sac-TMT plus pembrolizumab with TPC.
- For all participants, BICR assessed OS for sac-TMT plus pembrolizumab with sac-TMT.
- For all participants, BICR assessed DOR for sac-TMT, sac-TMT plus pembrolizumab with TPC according to RECIST 1.1.
- For all participants, BICR assessed mean change in health-related quality of life (HRQoL) since baseline for sac-TMT and TPC using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire 30 (EORTC QLQ-C30).
- For all participants, EORTC QLQ-C30 was used to compare mean change in HRQoL since baseline for sac-TMT plus pembrolizumab with TPC.
- Evaluate the safety and tolerability of sac-TMT, sac-TMT plus pembrolizumab, and TPC.
Test Drug
注射用凍晶粉末
注射劑
注射劑
Active Ingredient
MK-2870 (Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023; Sacituzumab Tirumotecan)
Pembrolizumab (Humanized anti-PD-1 mAb)
Pembrolizumab (Humanized anti-PD-1 mAb)
Dosage Form
048
270
270
Dosage
200 mg
100mg/ 4mL
100mg/ 4mL
Endpoints
• PFS: Time from random assignment to the first recorded disease progression or death from any cause, whichever comes first.
• OS: Time from random assignment to death from any cause.
• OS: Time from random assignment to death from any cause.
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
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
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
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
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
-
Taiwan
28 participants
-
Global
1000 participants
