Clinical Trials List
Protocol NumberMK-5890-003
NCT Number(ClinicalTrials.gov Identfier)NCT06829199
Completed
2025-02-01 - 2033-12-31
Phase II
Recruiting3
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 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer
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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
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Li-Yu Lee Division of Others -
- 周旭桓 Division of General Surgery
- Mengting Peng Division of Hematology & Oncology
- 沈士哲 Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
- 阮昱翔 Division of Radiology
- Wen-Chi Shen Division of Hematology & Oncology
- Wen-Ling Kuo Division of General Surgery
- Chan-Keng Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Ting Lee
Co-Principal Investigator
- Shang-Hung Chen Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- Zhu-Jun Loh Division of General Surgery
- Chun-Hui Lee Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- 楊舜如 Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Early Triple Negative Breast Cancer
Objectives
The objectives of this study are:
- To test the safety of preoperative administration of the investigational drug combination
- To understand the efficacy of preoperative administration of the investigational drug combination
Test Drug
注射劑
注射劑
注射劑
Active Ingredient
MK-5890
Pembrolizumab (Humanized anti-PD-1 mAb)
Pembrolizumab (Humanized anti-PD-1 mAb)
Dosage Form
270
270
270
Dosage
50 mg/mL
100 mg/ 4 mL
100 mg/ 4 mL
Endpoints
- Adverse events
- Treatment discontinuation due to adverse events
- Complete pathological response
- Treatment discontinuation due to adverse events
- Complete pathological response
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
Has provided a core needle biopsy for tissue diagnosis of the current breast cancer less than 29 days prior to the date of informed consent
Has centrally confirmed diagnosis of BC that is triple-negative based on the American Society of Clinical Oncology/College of American Pathologists guidelines
Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
Has left ventricle ejection fraction of ≥50% as assessed by echocardiogram or multigated acquisition scan performed at screening
Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin
The main inclusion criteria include but are not limited to the following:
Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
Has provided a core needle biopsy for tissue diagnosis of the current breast cancer less than 29 days prior to the date of informed consent
Has centrally confirmed diagnosis of BC that is triple-negative based on the American Society of Clinical Oncology/College of American Pathologists guidelines
Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
Has left ventricle ejection fraction of ≥50% as assessed by echocardiogram or multigated acquisition scan performed at screening
Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has documented Grade ≥2 peripheral neuropathy
Has uncontrolled or significant cardiovascular disease
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Has received prior systemic anticancer therapy
Has undergone excisional biopsy of the primary tumor and/or axillary lymph node dissection prior to study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has active autoimmune disease that has required systemic treatment in the past 2 years with need for disease modifying agents such as corticosteroids or immunosuppressive drugs
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agent or study intervention, any of its excipients, and/or to another biologic therapy
Has a history of allogeneic tissue/solid organ transplant
The main exclusion criteria include but are not limited to the following:
Has documented Grade ≥2 peripheral neuropathy
Has uncontrolled or significant cardiovascular disease
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Has received prior systemic anticancer therapy
Has undergone excisional biopsy of the primary tumor and/or axillary lymph node dissection prior to study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has active autoimmune disease that has required systemic treatment in the past 2 years with need for disease modifying agents such as corticosteroids or immunosuppressive drugs
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agent or study intervention, any of its excipients, and/or to another biologic therapy
Has a history of allogeneic tissue/solid organ transplant
The Estimated Number of Participants
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Taiwan
12 participants
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Global
100 participants
