A clinical study of patritumab deruxtecan in people with breast cancer
Key facts
- Where
- Badalona, Barcelona, Córdoba, Madrid, Málaga és Valencia, SpanyolországSee the 7 sites
- Phase
- 2. fázis
Where in Spanyolország
- Institut Catala d'OncologiaBadalona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Reina SofiaCórdoba, SpanyolországTaking people
- Clinica Universidad de NavarraMadrid, SpanyolországTaking people
- Hospital Universitario 12 de OctubreMadrid, SpanyolországTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpanyolországTaking people
- Fundación Instituto Valenciano de OncologíaValencia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2024-514376-40-00
- Record updated
- 2026. október 8.
- Original description
1. Part 1 Objective: To evaluate safety and tolerability of neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before carboplatin/ paclitaxel plus pembrolizumab. 2. Part 2 Objective: To compare HER3-DXd plus pembrolizumab before carboplatin/paclitaxel plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab followed by AC/EC plus pembrolizumab with respect to rate of pCR (ypT0/Tis ypN0) at the time of definitive surgery, as assessed by local pathologist. 3. Part 2 Objective: To compare HER3-DXd plus pembrolizumab after carboplatin/paclitaxel plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab followed by AC/EC plus pembrolizumab with respect to rate of pCR (ypT0/Tis ypN0) at the time of definitive surgery, as assessed by local pathologist. 4. Part 2: To evaluate safety and tolerability of study interventions in all arms.Read full original descriptionShow less
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)
1. Part 1 Objective: To evaluate safety and tolerability of neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before carboplatin/ paclitaxel plus pembrolizumab. 2. Part 2 Objective: To compare HER3-DXd plus pembrolizumab before carboplatin/paclitaxel plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab followed by AC/EC plus pembrolizumab with respect to rate of pCR (ypT0/Tis ypN0) at the time of definitive surgery, as assessed by local pathologist. 3. Part 2 Objective: To compare HER3-DXd plus pembrolizumab after carboplatin/paclitaxel plus pembrolizumab versus carboplatin/paclitaxel plus pembrolizumab followed by AC/EC plus pembrolizumab with respect to rate of pCR (ypT0/Tis ypN0) at the time of definitive surgery, as assessed by local pathologist. 4. Part 2: To evaluate safety and tolerability of study interventions in all arms.
Inclusion: 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: Has concurrent active HBV and HCV infection; 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 uncontrolled or significant cardiovascular disease before randomization; Has known additional malignancy that is progressing or has required active treatment within the past 5 years; Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current or suspected ILD; Has an active infection requiring systemic therapy; Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness; Has any history of or evidence of any current leptomeningeal carcinomatosis; Has clinically significant corneal disease; Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease; Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection; Has metastatic (Stage IV) breast cancer or cN3 nodal involvement; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.