Breast NeoplasmsPhase 1/2NCT06686394
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
A Phase 1/2 study testing Patritumab deruxtecan, Trastuzumab and Trastuzumab Biosimilar in people with Breast Neoplasms and Breast Cancer, run by Merck Sharp & Dohme LLC at 18 sites in 6 countries.
Trial summary
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- Patritumab deruxtecan, Trastuzumab and Trastuzumab Biosimilar
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 26 Feb 2025to 2 Aug 2032
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
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- Part 1 Arm 1:
- Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
- Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment
- Part 1 Arm 2:
- -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
- Part 1 Arm 3:
- -Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.
- Part 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC).
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Uncontrolled or significant cardiovascular disease
- Has any history of (noninfectious) interstitial lung disease (ILD)/ pneumonitis irrespective of steroid use or has current ILD or suspected ILD
- Has clinically severe respiratory compromise
- Has any history of or evidence of any current leptomeningeal disease
- Has clinically significant corneal disease
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- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
- HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Part 1: Evidence of spinal cord compression or brain metastases
- Part 2: Evidence of spinal cord compression or brain/CNS metastases.
- Has an active infection requiring systemic therapy
- Concurrent active HBV and HCV infection
- Has had major surgical procedure (excluding placement of vascular access) less than 28 days
- Part1: Arm 3 ONLY
- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting
Trial locations and contacts
18 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 6 countries
United States5 sites, 5 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 0057)
Aurora, Colorado, 80045
Study Coordinator, 720-848-1030
- Recruiting
Dana-Farber Cancer Institute ( Site 0050)
Boston, Massachusetts, 02215
Study Coordinator, 877-338-7425
- Recruiting
Inova Schar Cancer Institute ( Site 0051)
Fairfax, Virginia, 22031
Study Coordinator, 571-472-4724
- Recruiting
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville, South Carolina, 29605
Study Coordinator, 864-455-3600
- Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick, New Jersey, 08901
Study Coordinator, 732-235-2465
Canada4 sites, 4 recruiting
- Recruiting
Kingston General Hospital ( Site 0061)
Kingston, Ontario, K7L 2V7
Study Coordinator, 6135336541
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0004)
Montreal, Quebec, H2X 3E4
Study Coordinator, (514)890-8000 x20737
- Recruiting
Jewish General Hospital ( Site 0003)
Montreal, Quebec, H3T 1E2
Study Coordinator, 514-340-8222
- Recruiting
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, M5G 2M9
Study Coordinator, 416-946-4501
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus ( Site 0011)
Haifa, 3109601
Study Coordinator, 04-7776234
- Recruiting
Rabin Medical Center ( Site 0012)
Petah Tikva, 4941492
Study Coordinator, +972-505533121
- Recruiting
Sheba Medical Center ( Site 0010)
Ramat Gan, 5265601
Study Coordinator, 03-5304498
United Kingdom3 sites, 3 recruiting
- Recruiting
The Beatson West of Scotland Cancer Centre ( Site 0043)
Glasgow, Glasgow City, G12 0YN
Study Coordinator, +441413017000
- Recruiting
University College London Hospital ( Site 0041)
London, Camden, NW1 2PG
Study Coordinator, +442034472930
- Recruiting
St Bartholomew s Hospital ( Site 0040)
London, London, City of, EC1A 7BE
Study Coordinator, +442073777000
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital ( Site 0030)
Seoul, 03080
Study Coordinator, 82-2-2072-0850
- Recruiting
Asan Medical Center ( Site 0031)
Seoul, 05505
Study Coordinator, +82-2-1688-7575
Japan1 site, 1 recruiting
- Recruiting
Nagoya City University Hospital ( Site 0020)
Nagoya, Aichi-ken, 467-8602
Study Coordinator, +81-52-851-5511
About this study
Official title: HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
- About the safety and how well people tolerate of patritumab deruxtecan
- How many people have the cancer respond (get smaller or go away) to treatment
Read the detailed description
The following countries will be participating in the trial: Canada, United Kingdom, Israel, Japan, South Korea, and USA.
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar, Pertuzumab, Tucatinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patritumab deruxtecanBiological
Also called MK-1022, HER3-DXd, U3-1402
Patritumab deruxtecan administered via IV infusion
TrastuzumabBiological
Also called Herceptin®
Trastuzumab administered via IV infusion
Trastuzumab BiosimilarBiological
Also called Trazimera®, Ogivri®, Herzuma®, Ontruzant®
Trastuzumab biosimilar administered via IV infusion
PertuzumabBiological
Pertuzumab administered via IV infusion
TucatinibBiological
Tucatinib administered as oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Patritumab deruxtecan plus trastuzumab | Experimental | Participants receive patritumab deruxtecan intravenous (IV) infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. Receives: Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar |
| Part 1: Patritumab deruxtecan plus pertuzumab and trastuzumab | Experimental | Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. Receives: Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar; Biological: Pertuzumab |
| Part 1: Patritumab deruxtecan plus trastuzumab and tucatinib | Experimental | Participants receive patritumab deruxtecan IV infusion and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks), and tucatinib is administered orally twice daily for each 21-day cycle, until disease progression, intolerable toxicity, or investigator decision. Receives: Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar; Biological: Tucatinib |
| Part 2: Patritumab deruxtecan plus pertuzumab and trastuzumab | Experimental | Participants receive patritumab deruxtecan IV infusion, pertuzumab IV infusion, and trastuzumab or trastuzumab biosimilar IV infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. Receives: Biological: Patritumab deruxtecan; Biological: Trastuzumab; Biological: Trastuzumab Biosimilar; Biological: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The number of participants who experience a DLT will be presented.
Measured: Up to 21 days
Part 1: Number of Participants with One or More Adverse Events (AEs)
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.
Measured: Up to approximately 36 months
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
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 discontinue study treatment due to an AE will be presented.
Measured: Up to approximately 12 months
Part 2: Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR)will be presented.
Measured: Up to approximately 36 months
Secondary outcomes (13)
Part 1: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Antibody-Drug Conjugate (ADC)
Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan ADC.
Measured: At designated time points (up to ~13 months)
Part 1: Trough Concentration (Ctrough) of Patritumab Deruxtecan ADC
Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan ADC.
Measured: At designated time points (up to ~13 months)
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan ADC
Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan ADC.
Measured: At designated time points (up to ~13 months)
Part 1: Maximum Plasma Concentration (Cmax) of Total Patritumab Deruxtecan Antidrug Antibody (ADA)
Blood samples collected at designated time points will be used to determine the Cmax of total patritumab deruxtecan ADA.
Measured: At designated time points (up to ~13 months)
Part 1: Trough Concentration (Ctrough) of Total Patritumab Deruxtecan ADA
Blood samples collected at designated time points will be used to determine the Ctrough of total patritumab deruxtecan ADA.
Measured: At designated time points (up to ~13 months)
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Total Patritumab Deruxtecan ADA
Blood samples collected at designated time points will be used to determine the AUC of total patritumab deruxtecan ADA.
Measured: At designated time points (up to ~13 months)
Part 1: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the Cmax of patritumab deruxtecan free payload.
Measured: At designated time points (up to ~13 months)
Part 1: Trough Concentration (Ctrough) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the Ctrough of patritumab deruxtecan free payload.
Measured: At designated time points (up to ~13 months)
Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of Patritumab Deruxtecan Free Payload
Blood samples collected at designated time points will be used to determine the AUC of patritumab deruxtecan free payload.
Measured: At designated time points (up to ~13 months)
Part 2: Duration of Response (DOR)
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is alsoc onsidered PD. DOR as assessed by BICR will be presented.
Measured: Up to approximately 36 months
Part 2: Progression Free Survival (PFS)
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD)or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Measured: Up to approximately 36 months
Part 2: Number of Participants with One or More AEs
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.
Measured: Up to approximately 36 months
Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
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.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start26 Feb 2025
- Primary completion2 Aug 2032 (estimated)
- Study completion2 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 181 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686394
- Sponsor's protocol ID
- 1022-009
- Other IDs
- MK-1022-009, jRCT2041250022, 2026-528266-19, U1111-1346-4321
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf