> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-patritumab-deruxtecan-plus-pembrolizumab-with-other-64ff8213-ee7c-463a-b715-d55ee9bf2f70 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Participants 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Start date 2025-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Dates **Completion date** 2034-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **First posted** 2025-01-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Registry last updated** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Primary completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Start date** 2025-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Size and sites **Participants** 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Planned participants** 372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Identifiers **Registry ID** NCT06797635 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **ClinicalTrials.gov ID** NCT06797635 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Outcomes ### Primary outcomes 1. Part 1: Number of Participants Experiencing an Adverse Event (AE) Timeframe: 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. 2. Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) Timeframe: 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. 3. Part 1: Number of Participants who Discontinued Study Treatment Due to an AE Timeframe: 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. 4. Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 Timeframe: 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. 5. Part 2: Number of Participants Experiencing an AE Timeframe: 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. 6. Part 2: Number of Participants who Discontinued Study Treatment Due to an AE Timeframe: 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. ### Secondary outcomes 1. Part 2: pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0 Timeframe: Up to \~30 weeks pCR-no DCIS (ypT0 ypN0) is defined as the absence of residual invasive and in situ 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. 2. Part 2: Event-Free Survival (EFS) Timeframe: Up to \~100 months EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first. 3. Part 2: Overall Survival (OS) Timeframe: Up to \~100 months OS is defined as the time from randomization to date of death due to any cause. 4. Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS) Timeframe: Up to \~100 months DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed or death due to any cause, whichever occurs first. 5. Part 2: Residual Cancer Burden (RCB) Timeframe: Up to \~30 weeks RCB is defined as residual disease in either the breast or lymph node at the time of surgery. RCB score provides a continuous measurement of the extent of residual cancer. There are four RCB classes: RCB-0 (RCB score 0), RCB-1 (0\\< RCB score \\<1.36), RCB-2 (1.36 \\3.28). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Sites - UCLA Hematology/Oncology - Parkside ( Site 0021)Santa Monica, United StatesRecruiting - Orchard Healthcare Research Inc. ( Site 0006)Skokie, United StatesRecruiting - Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)Billings, United StatesRecruiting - Northwest Cancer Specialists (Compass Oncology) ( Site 8003)Tigard, United StatesRecruiting - SCRI Oncology Partners ( Site 7000)Nashville, United StatesRecruiting - Texas Oncology - DFW ( Site 8000)Dallas, United StatesRecruiting - Houston Methodist Hospital ( Site 0022)Houston, United StatesRecruiting - Virginia Oncology Associates (VOA) ( Site 8001)Norfolk, United StatesRecruiting - Seoul National University Hospital ( Site 2400)Seoul, South KoreaRecruiting - Severance Hospital, Yonsei University Health System ( Site 2402)Seoul, South KoreaRecruiting - Asan Medical Center ( Site 2401)Seoul, South KoreaRecruiting - Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)Badalona, SpainRecruiting - Clinica Universidad de Navarra ( Site 1703)Madrid, SpainRecruiting - Hospital Universitario Reina Sofia ( Site 1702)Córdoba, SpainRecruiting - Taichung Veterans General Hospital ( Site 2502)Taichung, TaiwanRecruiting - National Cheng Kung University Hospital ( Site 2503)Tainan, TaiwanRecruiting - Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)Taipei, TaiwanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers (3) - MK-1022-010 - U1111-1307-7867 - 2024-514376-40-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06797635) ## Related records ### Drugs (9) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cyclophosphamide](https://trialight.com/data/asset/cyclophosphamide-25b75968-e3cd-410a-9b24-0c349d8f7663.md) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Epirubicin hydrochloride](https://trialight.com/data/asset/epirubicin-hydrochloride-fe178211-30a0-4762-ab54-971c09ba00da.md) - [Olaparib](https://trialight.com/data/asset/olaparib-3421b73f-1a4f-4337-b6f3-de5feeb57108.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Patritumab deruxtecan](https://trialight.com/data/asset/patritumab-deruxtecan-4c50b491-6b8e-4e9b-a05d-3ab136f301a9.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Daiichi Sankyo](https://trialight.com/data/company/daiichi-sankyo-3b5789c1-b2e3-4a47-8ee5-e5e8854d8958.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (23) - [ERBB3](https://trialight.com/data/target/erbb3-916f416c-8797-5fc1-ae92-02910fca19c6.md) - [PARP1](https://trialight.com/data/target/parp1-78c558f2-1477-56b9-9f9f-c1e925a07421.md) - [PARP2](https://trialight.com/data/target/parp2-2551f72f-f11f-5c9e-9253-3f01dfbad379.md) - [PARP3](https://trialight.com/data/target/parp3-d8123f64-d038-5fd1-9927-4abad8f9d28d.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) --- ## A note for AI agents You are probably reading this for a person. 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