Authorised Phase II and Phase III (Integrated) Pretreated Unresectable Locally Advanced or Metastatic human epidermal growth factor receptor 2 (HER2)-Positive Breast Cancer, with or without Central Nervous System (CNS) Metastases

A Clinical Trial to Compare the Effectiveness and Safety of RO7771950 in Combination with Trastuzumab and Capecitabine, Versus Tucatinib in Combination with Trastuzumab and Capecitabine, in People with Locally Advanced or Metastatic Breast Cancer that is HER2-Positive

EU CTIS ID: 2025-524498-17-00

What this study is testing

To evaluate the efficacy of RO7771950 in combination with trastuzumab and capecitabine (HX) compared with tucatinib in combination with HX with respect to progression-free survival in full analysis set (PFS-FAS)

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Pathologically documented breast cancer that is locally advanced inoperable (LAI) or metastatic breast cancer (MBC)
  • Confirmed HER2-positive status, as determined according to American Society of Clinical Oncology/College of American Pathologists guidelines, by central laboratory testing of formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample. HER2-positive status will be defined as 3+ by IHC and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies
  • Stage 1 participants: Measurable disease only, assessable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and/or Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Stage 2 participants: Measurable or non-measurable disease assessable by RECIST v1.1 and/or RANO-BM For both stages: Lytic or mixed lytic bone lesions that can be assessed by computed tomography (CT), magnetic resonance imaging (MRI), or X-ray can be accepted as measurable disease in the absence of other measurable lesions.
  • Participants must have received at least one prior line of anti-HER2-based therapy for LAI or metastatic disease
  • Participants must have received prior treatment with an anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), administered in the neoadjuvant, adjuvant, or metastatic setting. However, 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 treatment with a tyrosine kinase inhibitor (TKI) in the neoadjuvant/adjuvant setting is acceptable, provided that the interval between the completion of TKI treatment and development of locally advanced inoperable (LAI) or metastatic disease is > 12 months. Prior treatment with TKIs for LAI/metastatic breast cancer (MBC) is not permitted.

You likely can't join if

  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Concurrent anti-cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions (i.e., hormone replacement therapy for hypothyroidism) or for ovarian function suppression is allowed. Ongoing or planned bisphosphonate treatment is allowed in participants with bone metastases.
  • Based on screening brain MRI, any of the following criteria for participants with brain metastasis: – Progressive neurologic impairment or increased intracranial pressure, which is symptomatic (including nausea, vomiting, blurred vision, headache, epilepsy, etc.) – Any intracranial lesion that is expected to require immediate local therapy. After local therapy, the participant can be re-screened for the protocol. – Requirement for systemic corticosteroids for management of CNS symptoms at a total daily dose of 2 mg of dexamethasone (or equivalent). A stable or tapering dose of 2 mg is permitted. – Requirement for anti-epileptic medication for seizure control, with the exception of stable-dose levetiracetam
  • Participants who meet one of the following cardiac criteria: – Congestive heart failure (CHF; New York Heart Association [NYHA] functional classification) of 2 – Clinically significant peripheral arterial disease, like coronary artery disease, hypertrophic cardiomyopathy, or dilated cardiomyopathy – Abnormalities in the ECG measurements: such as first-degree heart block, second degree heart block, third-degree heart block, prolonged PR interval: 0.20 s – Any clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention – Unstable angina – Myocardial infarction within the past 6 months – Percutaneous transluminal coronary angioplasty/stenting, coronary artery bypass graft within 6 months of the first dose of the study treatment – QT interval corrected through use of Fridericia's formula (QTcF) prolongation (470 ms for women and 450 ms for men), a known history of QTcF prolongation or Torsade de Pointes; or is on drugs that are required for existing medical conditions and that may result in QT prolongation (e.g., anti-arrhythmic drugs) – Poorly controlled hypertension (e.g., systolic  180 mm Hg or diastolic  100 mmHg) – History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy) – Coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing) – Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
  • Participants with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Participants with a diagnosis of hepatitis B or C that has been treated and cleared (viral genetic test should fulfil the local laboratory definition for "cleared"), and normal liver function are eligible to participate in the study if the other eligibility parameters are met. Virologic testing should be conducted according to local institutional practices

The study team makes the final eligibility decision.

Where it's taking place

  • Argentina
  • Israel
  • Turkey
  • Brazil
  • Chile
  • Canada
  • Taiwan
  • Mexico
  • South Africa
  • Thailand
  • New Zealand
  • China
  • Australia
  • United States
  • United Kingdom
  • Korea, Republic of
  • Ukraine

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Argentina; Israel; Turkey; Brazil; Chile; Canada and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.