Comparing 4 approaches for breast neoplasms
Official title: 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)
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
- Phase 1
- 4 groups
- Sites in Kingston, Toronto and 1 more city
- Recruiting
Interventions (5)
- Biological therapy
Patritumab deruxtecan
Patritumab deruxtecan administered via IV infusion
- Biological therapy
Trastuzumab
Trastuzumab administered via IV infusion
- Biological therapy
Trastuzumab Biosimilar
Trastuzumab biosimilar administered via IV infusion
- Biological therapy
Pertuzumab
Pertuzumab administered via IV infusion
- Biological therapy
Tucatinib
Tucatinib administered as oral tablets
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Kingston General Hospital ( Site 0061)
Kingston, Ontario
- Recruiting
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0004)
Montreal, Quebec
- Recruiting
Jewish General Hospital ( Site 0003)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention
- +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
- +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → include but are not limited to the following:
- +Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
- +Part 1 ArmArmOne of the groups in a study, each receiving something different.Read more → 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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +Part 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC).
Exclusion
- −Has any history of or evidence of any current leptomeningeal disease
- −Part 1: Evidence of spinal cord compression or brain metastases
- −Part 2: Evidence of spinal cord compression or brain/CNS metastases.
- −HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- −Concurrent active HBV and HCV infection
- −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 clinically significant corneal disease
- −Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
- −Known additional malignancy that is progressing or has required active treatment within the past 3 years
- −Has an active infection requiring systemic therapy
- −Has had major surgical procedure (excluding placement of vascular access) less than 28 days
- −Part1: ArmArmOne of the groups in a study, each receiving something different.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Group A receives Patritumab deruxtecan and Trastuzumab, together with one or more of: Trastuzumab Biosimilar.
Registry label: A: Part 1: Patritumab deruxtecan plus trastuzumab
Groups B and D receive Patritumab deruxtecan, Pertuzumab and Trastuzumab, together with one or more of: Trastuzumab Biosimilar.
Registry label: B: Part 1: Patritumab deruxtecan plus pertuzumab and trastuzumab · D: Part 2: Patritumab deruxtecan plus pertuzumab and trastuzumab
Group C receives Patritumab deruxtecan, Trastuzumab and Tucatinib, together with one or more of: Trastuzumab Biosimilar.
Registry label: C: Part 1: Patritumab deruxtecan plus trastuzumab and tucatinib
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 181 people.
The study is currently expected to finish around August 2032.
The main measurement is taken over: Up to 21 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part 1: Number of Participants Experiencing Dose-Limiting Toxicity (DLT) — measured over Up to 21 days.
Part 1: Number of Participants with One or More Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to approximately 36 months.
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE — measured over Up to approximately 12 months.
Part 2: Objective Response Rate (ORR) — measured over Up to approximately 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06686394 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Patritumab deruxtecanBiological
Patritumab deruxtecan administered via IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About TrastuzumabBiological
Trastuzumab administered via IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Trastuzumab BiosimilarBiological
Trastuzumab biosimilar administered via IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PertuzumabBiological
Pertuzumab administered via IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About TucatinibBiological
Tucatinib administered as oral tablets
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 21 days.
The study as a whole is currently expected to finish around 2032-08-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 181 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Kingston, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
Someone at Concord will read your request and email you. The study team decides who takes part.
Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.