Comparing 3 approaches for HER2-positive breast cancer
Official title: RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases
- Phase 2
- 3 groups
- Sites in Ottawa, Toronto and 3 more cities
- Recruiting
Interventions (4)
- Medication
RO7771950
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
- Medication
Tucatinib
Participants will receive a dose of tucatinib PO BID.
- Medication
Trastuzumab
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
- Medication
Capecitabine
Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
Canadian Sites (8)
8 of 8 recruiting
- Recruiting
Ottawa General Hospital
Ottawa, Ontario
- Recruiting
Sunnybrook Odette Cancer Centre
Toronto, Ontario
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario
- Recruiting
Hopital Charles Le Moyne
Greenfield Park, Quebec
- Recruiting
Hopital Maisonneuve-Rosemont
Montreal, Quebec
- Recruiting
CHUM
Montreal, Quebec
- Recruiting
McGill University Health Centre - Glen Site
Montreal, Quebec
- Recruiting
Hospital Du Saint-Sacrement
Québec, Quebec
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.
- +Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.
- +Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.
- +At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.
- +Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → if approved standard-of-care (SOCStandard of careThe treatment normally given for a condition outside a study.Read more →) anti-HER2 ADC is not locally accessible at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or if there is a prospectively documented clinical contraindication.
- +Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is \> 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI/MBC is not permitted.
- +Has protocolProtocolThe detailed plan a study must follow.Read more →-defined adequate organ and bone marrow function.
- +Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → left ventricular ejection fraction (LVEF) ≥ 50%.
Exclusion
- −Known active/untreated hepatitis B or C or chronic liver disease.
- −Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.
- −Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events/interventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.
- −Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
- −Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.
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 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive RO7771950, together with one or more of: Trastuzumab and Capecitabine.
Registry label: A: Arm A - RO7771950 Dose Type 1 · B: Arm B - RO7771950 Dose Type 2
Group C, the comparison group, receives Tucatinib, together with one or more of: Trastuzumab and Capecitabine.
Registry label: C: Arm C - Tucatinib
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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.
One group receives an existing treatment, so the two can be compared.
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 650 people.
The study is currently expected to finish around September 2032.
The main measurement is taken over: Approximately 35 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) — measured over Approximately 35 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07413939 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 RO7771950Drug
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TucatinibDrug
Participants will receive a dose of tucatinib PO BID.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TrastuzumabDrug
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CapecitabineDrug
Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
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.
One group receives an existing treatment so the two can be compared.
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.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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: Approximately 35 months.
The study as a whole is currently expected to finish around 2032-09-29.
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 650 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Greenfield Park, Quebec, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Albany, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.
Other Sites (2)
New York Oncology Hematology, P.C.
Albany, New York, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Think this trial might be right for you?
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See if this trial could fit youThis 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.