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-Postivie Breast Cancer, With or Without Central Nervous System Metastases
New drug RO7771950 tested against tucatinib for advanced HER2+ breast cancer
Plain English Summary
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 is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying HER2-positive Breast Cancer. This trial tests a new drug, RO7771950, combined with standard treatments (trastuzumab and capecitabine) against another drug, tucatinib, also with standard treatments. It is for patients with HER2-positive breast cancer that has spread or cannot be removed, and who have previously been treated for this advanced stage. Participation involves taking study drugs and attending regular clinic visits for assessments and monitoring. Standard treatment options for this condition include chemotherapy, hormone therapy, and other targeted therapies, depending on prior treatments and specific cancer characteristics. The trial aims to enroll 650 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with HER2-positive breast cancer that is locally advanced or has spread to other parts of the body. Must have received at least one prior treatment for advanced HER2-positive breast cancer. Can have brain metastases or leptomeningeal metastases, or have had them previously treated. Individuals with adequate organ function, a performance status of 0 or 1, and good heart function are eligible. This trial is studying HER2-positive Breast Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
Progression-free survival means the trial will measure how long patients live without their cancer getting worse, which is important for maintaining quality of life and delaying disease progression. The specific primary outcome measures are: Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) (Approximately 35 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a significant need for more effective treatments for patients with advanced HER2-positive breast cancer, particularly those with brain metastases, by evaluating a novel drug that As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HER2-positive Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant market of HER2-positive breast cancer patients with limited treatment options after progression on existing therapies, suggesting a strong unmet need and potential for Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 650 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific treatments being compared and what to expect regarding side effects. Understand the schedule of clinic visits, tests, and how you will take the study medications at home. Discuss any other medical conditions or medications you are taking to ensure they don't interfere with the study. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 650 participants
Interventions
- DRUG: RO7771950 — Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
- DRUG: Tucatinib — Participants will receive a dose of tucatinib PO BID.
- DRUG: Trastuzumab — Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
- DRUG: Capecitabine — Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
Primary Outcomes
- Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) (Approximately 35 months)
Secondary Outcomes
- Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR (Approximately 35 months)
- Overall Survival in Full Analysis Set (OS-FAS) (Approximately 53 months)
- Objective Response Rate (ORR) by BICR (Approximately 35 months)
- Duration of Response (DOR) as per BICR (Approximately 35 months)
- Clinical Benefit Rate (CBR) as per BICR (Approximately 35 months)
Full Eligibility Criteria
Inclusion Criteria: * Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory * Measurable disease only as per by RECIST v1.1/RANO-BM in stage 1. Non-measurable disease allowed in stage 2. * Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases * 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 for whom prior ADC therapy was not appropriate (e.g., due to lack of access or being medically unfit) may be considered for enrollment. * 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 protocol-defined adequate organ and bone marrow function * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Baseline left ventricular ejection fraction (LVEF) \>/= 50% Exclusion Criteria: * Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment * Known active/untreated hepatitis B or C or chronic liver disease * 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
Frequently Asked Questions
What is clinical trial NCT07413939?
NCT07413939 is a Phase 3 INTERVENTIONAL study titled "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." It is currently not yet recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 650 participants.
What conditions does NCT07413939 study?
This trial investigates treatments for HER2-positive Breast Cancer. The primary condition under study is HER2-positive Breast Cancer.
What treatments are being tested in NCT07413939?
The interventions being studied include: RO7771950 (DRUG), Tucatinib (DRUG), Trastuzumab (DRUG), Capecitabine (DRUG). Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
What does Phase 3 mean for NCT07413939?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07413939?
This trial is currently "Not Yet Recruiting." It started on 2026-04-30. The estimated completion date is 2032-08-28.
Who is sponsoring NCT07413939?
NCT07413939 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07413939?
The trial aims to enroll 650 participants. The trial has not yet started recruiting.
How is NCT07413939 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07413939?
The primary outcome measures are: Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) (Approximately 35 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07413939?
The official record for NCT07413939 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07413939. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07413939 testing in simple terms?
This trial tests a new drug, RO7771950, combined with standard treatments (trastuzumab and capecitabine) against another drug, tucatinib, also with standard treatments. It is for patients with HER2-positive breast cancer that has spread or cannot be removed, and who have previously been treated for this advanced stage.
Why is this trial significant?
This trial addresses a significant need for more effective treatments for patients with advanced HER2-positive breast cancer, particularly those with brain metastases, by evaluating a novel drug that As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07413939?
Common side effects may include diarrhea, nausea, fatigue, and skin reactions. Potential risks include liver problems, heart issues, and effects on blood counts. Specific risks related to RO7771950 and tucatinib will be discussed by the study team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07413939?
Ask your doctor about the specific treatments being compared and what to expect regarding side effects. Understand the schedule of clinic visits, tests, and how you will take the study medications at home. Discuss any other medical conditions or medications you are taking to ensure they don't interfere with the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07413939 signal from an investment perspective?
This trial targets a significant market of HER2-positive breast cancer patients with limited treatment options after progression on existing therapies, suggesting a strong unmet need and potential for This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking study drugs and attending regular clinic visits for assessments and monitoring. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.