Clinical Trials in the USA / NCT06797635
Recruiting
Phase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT06797635 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Breast NeoplasmsBreast Cancer
Investigational drug(s) / intervention(s)
Patritumab deruxtecan →Pembrolizumab →Paclitaxel →Carboplatin →Doxorubicin hydrochloride →Epirubicin hydrochloride →Cyclophosphamide →Capecitabine →Olaparib →
Patritumab deruxtecan: Administered via IV infusion as neoadjuvant treatment
Pembrolizumab: Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Paclitaxel: Administered via IV infusion as neoadjuvant treatment
Carboplatin: Administered via IV infusion as neoadjuvant treatment
Doxorubicin hydrochloride: Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Epirubicin hydrochloride: Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Cyclophosphamide: Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Capecitabine: Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
Olaparib: Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
Study summary
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:
* About the safety of the study treatments and if people tolerate them
* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.
Eligibility
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
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has uncontrolled or significant cardiovascular disease before randomization
* 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 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 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 concurrent active HBV and HCV infection
* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness
Primary outcome measure(s)
- Part 1: Number of Participants Experiencing an Adverse Event (AE) — Up to ~43 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 1. - Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to 21 days
A DLT is defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, assessed by investigator as drug-related: Grade (gr) 3 or 4 nonhematologic toxicity (with exceptions); gr 3 or gr 4 laboratory values (with exceptions); gr 3 or 4 febrile neutropenia; prolonged delay (\>2 weeks) in initiating Cycle 2 (cycle length = 3 weeks) due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1; interstitial lung disease as per investigator; any other gr ≥3 pulmonary toxicity; or gr 5 toxicity. - Part 1: Number of Participants who Discontinued Study Treatment Due to an AE — Up to ~30 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 1. - Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 — Up to ~30 weeks
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery. - Part 2: Number of Participants Experiencing an AE — Up to ~103 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 2. - Part 2: Number of Participants who Discontinued Study Treatment Due to an AE — Up to ~90 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 2.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Hematology/Oncology - Parkside ( Site 0021) | Santa Monica | California | Recruiting |
| Orchard Healthcare Research Inc. ( Site 0006) | Skokie | Illinois | Recruiting |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) | Billings | Montana | Recruiting |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8003) | Tigard | Oregon | Recruiting |
| SCRI Oncology Partners ( Site 7000) | Nashville | Tennessee | Recruiting |
| Texas Oncology - DFW ( Site 8000) | Dallas | Texas | Recruiting |
| Houston Methodist Hospital ( Site 0022) | Houston | Texas | Recruiting |
| Virginia Oncology Associates (VOA) ( Site 8001) | Norfolk | Virginia | Recruiting |
| Seoul National University Hospital ( Site 2400) | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 2402) | Seoul | South Korea | Recruiting |
| Asan Medical Center ( Site 2401) | Seoul | South Korea | Recruiting |
| Institut Català d'Oncologia (ICO) - Badalona ( Site 1700) | Badalona | Catalonia | Recruiting |
| Clinica Universidad de Navarra ( Site 1703) | Madrid | Madrid, Comunidad de | Recruiting |
| Hospital Universitario Reina Sofia ( Site 1702) | Córdoba | Spain | Recruiting |
| Taichung Veterans General Hospital ( Site 2502) | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital ( Site 2503) | Tainan | Taiwan | Recruiting |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501) | Taipei | Taiwan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06797635 on ClinicalTrials.gov ↗ ← All trials in the USA