Clinical Trials List
2024-03-15 - 2032-12-31
Phase III
Recruiting6
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
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/18
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
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
Co-Principal Investigator
- 周旭桓 無
- Mengting Peng 無
- Wen-Chi Shen 無
- Wen-Ling Kuo 無
- Chan-Keng Yang 無
- 沈士哲 無
- Yung-Chang Lin 無
- Chi-Chang Yu 無
- 阮昱翔 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Hui Lee Division of General Surgery
- Wei-Pang Chung
- 楊舜如
- Zhu-Jun Loh
- Shang-Hung Chen
- 魏慈慧
- Jui-Hung Tsai
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Frozen crystal powder for injection
Active Ingredient
MK-2870 ( Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023 )
Dosage Form
048
Dosage
200mg/vial
Endpoints
Inclution Criteria
Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
Is a chemotherapy candidate
Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
Has adequate organ function
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
Has breast cancer amenable to treatment with curative intent
Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
Active autoimmune disease that has required systemic treatment in the past 2 years
History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1200 participants
