Clinical Trials List
Protocol NumberMK-1022-010
NCT Number(ClinicalTrials.gov Identfier)NCT06797635
Not yet recruiting
2025-04-01 - 2035-12-31
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
An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)
-
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
- Kuan-Der Lee Division of General Surgery
- 劉佳樺 Division of General Surgery
- ZHENG-WEI ZHOU Division of General Surgery
- Huey-En Tzeng Division of General Surgery
- I-Chen Tsai Division of General Surgery
- HSIN-CHEN LIN Division of General Surgery
- 楊捷儒 Division of General Surgery
- Chi-Long Chen Division of General Surgery
- 王國鐘 Division of General Surgery
- 林慈恩 Division of General Surgery
- 楊陽生 Division of General Surgery
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 General Surgery
- Jui-Hung Tsai Division of General Surgery
- 陳慧雯 Division of General Surgery
- Wei-Pang Chung Division of General Surgery
- 黃怡菁 Division of General Surgery
- Zhu-Jun Loh Division of General Surgery
- Chun-Hui Lee Division of General Surgery
- 楊舜如 Division of General Surgery
- 黃怡璇 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Breast Neoplasms 、Breast Cancer
Objectives
Primary Objectives
• Part 1 Objective: To evaluate the safety and tolerability of pre-treatment with patritumab deruxtecan (HER3 DXd) plus pembrolizumab prior to carboplatin/paclitaxel plus pembrolizumab.
• Part 2 Objective: To compare the pathological complete response (pCR) (ypT0/Tis ypN0) rate at decisive surgery with HER3 DXd plus pembrolizumab prior to carboplatin/paclitaxel plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab followed by AC (doxorubicin/cyclophosphamide)/EC (epirubicin/cyclophosphamide) plus pembrolizumab, as assessed by a local pathologist.
• Part 2 Objective: To compare the pCR (ypT0/Tis ypN0) rate at decisive surgery between HER3 DXd plus pembrolizumab following carboplatin/paclitaxel plus pembrolizumab and AC/EC plus pembrolizumab, as assessed by a local pathologist.
• Part 2: To assess the safety and tolerability of the trial treatment in all groups.
Secondary Objectives
• Part 2: To assess the rate of achieving pCR-free ductal carcinoma in situ (DCIS) (ypT0 ypN0) at decisive surgery in all groups, as assessed by a local pathologist.
• Part 2: To assess event-free survival (EFS) as assessed by the trial administrator in all groups.
• Part 2: To assess overall survival (OS) in all groups. • Part 2: Assessment of distal progression-free/distant recurrence-free survival (DPDRFS) by the trial administrator in all groups.
• Part 2: Assessment of RCB in all groups at the time of decisive surgery by local pathologists using the MD Anderson Residual Cancer Burden (RCB) calculator.
Test Drug
注射劑
注射劑
注射劑
Active Ingredient
Patritumab Deruxtecan
Pembrolizumab
Pembrolizumab
Dosage Form
270
270
270
Dosage
100mg/Vial (製備後為20 mg/mL)
100mg/4mL/vial
100mg/4mL/vial
Endpoints
Part 1: Adverse Events (AEs).
Dose-limiting toxicities (DLTs).
Treatment discontinuation due to AEs.
Part 2: pCR (ypT0/Tis ypN0): No residual invasive cancer was observed in the completely excised breast smear and all sampled regional lymph nodes, as assessed by hematoxylin and eosin staining after completion of the preceding systemic therapy.
AEs.
Treatment discontinuation due to AEs.
Dose-limiting toxicities (DLTs).
Treatment discontinuation due to AEs.
Part 2: pCR (ypT0/Tis ypN0): No residual invasive cancer was observed in the completely excised breast smear and all sampled regional lymph nodes, as assessed by hematoxylin and eosin staining after completion of the preceding systemic therapy.
AEs.
Treatment discontinuation due to AEs.
Inclution Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
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 a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
The main inclusion criteria include but are not limited to the following:
Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
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 a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan
Exclusion Criteria
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has uncontrolled or significant cardiovascular disease before randomization
Has clinically significant corneal disease
Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
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
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD/pneumonitis cannot be ruled out by standard diagnostic assessments
Has an active infection requiring systemic therapy
Has concurrent active HBV and HCV infection
Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
The main exclusion criteria include but are not limited to the following:
Has uncontrolled or significant cardiovascular disease before randomization
Has clinically significant corneal disease
Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
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
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD/pneumonitis cannot be ruled out by standard diagnostic assessments
Has an active infection requiring systemic therapy
Has concurrent active HBV and HCV infection
Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
The Estimated Number of Participants
-
Taiwan
17 participants
-
Global
372 participants
