Use of tucatinib in combination therapy for HER2-positive breast cancer

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    What is this study about?

    This study examines whether tucatinib, combined with other medications, is more effective than a placebo in treating HER2-positive breast cancer. The research will also identify any side effects from the drug combination. Participants in this study have advanced breast cancer that is either unresectable (cannot be surgically removed) or metastatic (spread throughout the body). Participants will be randomly assigned to receive either tucatinib or a placebo, without knowing which one they are receiving. This method ensures the study’s fairness and accuracy. Additionally, all participants will receive trastuzumab and pertuzumab, two drugs effective against this cancer type. These will be administered every 21 days, either intravenously or subcutaneously, depending on the specific drug and combination used. The study has two main groups: one receiving a placebo and the other tucatinib, both alongside trastuzumab and pertuzumab.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Innsbruck , Austria

      Linz , Austria

      Schwaz , Austria

      Vienna , Austria

      Anderlecht , Belgium

      Brussels , Belgium

      Bruxelles-Capitale , Belgium

      Ottignies , Belgium

      Wilrijk , Belgium

      Brno , Czechia

      Praha 2 , Czechia

      Praha 4-Krc , Czechia

      Praha 5 , Czechia

      Praha , Czechia

      Helsinki , Finland

      Kuopio , Finland

      Tampere, Pirkanmaa , Finland

      Vaasa , Finland

      Avignon , France

      Besancon Cedex , France

      Bobigny , France

      Bordeaux , France

      Caen Cedex 5 , France

      Clermont-Ferrand , France

      Cotes d’Armor , France

      Dijon , France

      Lille , France

      Limoges Cedex , France

      Lyon cedex 08 , France

      Montpellier , France

      Montpellier , France

      Nice Cedex 2 , France

      Pierre Benite , France

      Rennes , France

      Rouen , France

      Saint Herblain cedex , France

      Saint-Cloude , France

      Strasbourg , France

      Augsburg , Germany

      Berlin , Germany

      Dusseldorf , Germany

      Erlangen , Germany

      Essen , Germany

      Esslingen , Germany

      Hamburg , Germany

      Hannover , Germany

      Koln , Germany

      Mannheim , Germany

      Mu00fcnchen , Germany

      Mu00fcnster , Germany

      Tubingen , Germany

      Ulm , Germany

      Wurzburg , Germany

      Regensburg , Germany

      Athens , Greece

      Cholargos , Greece

      Haidari , Greece

      Heraklion , Greece

      Larissa , Greece

      Marousi , Greece

      Maroussi , Greece

      Nea Efkarpia , Greece

      Patras , Greece

      Pireaus , Greece

      Thessaloniki , Greece

      Bologna , Italy

      Cona (FE) , Italy

      Genova , Italy

      Livorno , Italy

      Milano , Italy

      Misterbianco (CT) , Italy

      Monza , Italy

      Napoli , Italy

      Napoli , Italy

      Negrar Di Valpolicella , Italy

      Padova , Italy

      Parma , Italy

      Pavia , Italy

      Prato , Italy

      Rozzano (Milano) , Italy

      Torrette (AN) , Italy

      Trento , Italy

      Amsterdam , Netherlands

      Doedrecht , Netherlands

      Leeuwarden , Netherlands

      Nieuwegein , Netherlands

      Venlo , Netherlands

      Gdansk , Poland

      Gliwice , Poland

      Konin , Poland

      Lodz , Poland

      Lodz , Poland

      Opole , Poland

      Warszawa , Poland

      Braga , Portugal

      Coimbra , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Lisbon , Portugal

      Vila Nova de Gaia , Portugal

      Alicante , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Bilbao , Spain

      Caceres , Spain

      Girona , Spain

      Granada , Spain

      Lleida , Spain

      Madrid , Spain

      Madrid , Spain

      Malaga , Spain

      Murcia , Spain

      Palma de Mallorca , Spain

      Salamanca , Spain

      San Cristu00f3bal de la Laguna , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      Edinburgh , United Kingdom

      London , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Sutton , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial are as follows:

      1. Tucatinib – 300mg given by mouth (orally) twice daily
      2. Trastuzumab – 6mg/kg given into the vein (IV; intravenously) or 600mg injected under the skin (SC; subcutaneous) every 21 days
      3. Pertuzumab – 420mg given by IV every 21 days
      4. Combination product: Trastuzumab + Pertuzumab – 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase given by subcutaneous injection every 21 days. This may be given in place of trastuzumab and pertuzumab individually.
      5. Alternatively, for the control group, a Placebo is given orally twice daily, along with trastuzumab and pertuzumab at the aforementioned dosages and schedules.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible for the study based on diseases, you need to have the following:

      1. Centrally confirmed HER2+ breast carcinoma according to the 2018 ASCO/CAP guidelines prior to randomization, defined as a 3+ score on IHC and/or 2+ IHC and concurrent positive by ISH.
      2. Unresectable locally advanced or metastatic disease.
      3. If recurrent (after [neo]adjuvant therapy), you must be at least 6 months treatment-free from any trastuzumab and pertuzumab received in the early breast cancer setting for advanced HER2+ disease.
      4. You must have received 4-8 cycles of pre-study induction therapy including only trastuzumab, pertuzumab, and taxane as the first-line of therapy for the treatment of advanced breast cancer prior to study enrollment, without evidence of disease progression following completion of induction therapy.
      5. Known hormone receptor status (may be hormone receptor positive [HR+] or negative [HR-]) per local guidelines.
      6. Based on screening contrast-enhanced brain MRI, participants may have no evidence of brain metastases or untreated brain metastases which are asymptomatic.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria with Medical Term Explanations:

      • Centrally confirmed HER2+ breast carcinoma: Your breast cancer must be confirmed to have high levels of the HER2 protein, as per the 2018 American Society of Clinical Oncologists (ASCO) College of American Pathologists (CAP) guidelines. This confirmation is typically done through a test called immunohistochemistry (IHC) with a score of 3+ indicating high levels of HER2, or a score of 2+ on IHC with a positive result on an in situ hybridization (ISH) test to look for HER2 gene amplification.
      • Unresectable locally advanced or metastatic disease: Your breast cancer must not be removable by surgery and must be either advanced in the local region or have spread to other parts of the body (metastatic).
      • Treatment-free interval for certain drugs: If your cancer has come back after initial treatments (recurrent breast cancer), you need to have had at least a 6-month break from any previous treatments with trastuzumab and pertuzumab before enrollment in the study.
      • Completion of certain pre-study treatments: You must have completed 4-8 cycles of induction therapy with trastuzumab, pertuzumab, and taxane as the first line of treatment for advanced breast cancer, and not have shown any signs of disease progression after this treatment.
      • Known hormone receptor status: Your cancer’s hormone receptor status (positive or negative) needs to be clearly established by local medical standards.
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1: This scale measures how your disease affects your daily living abilities, with 0 indicating fully active, able to carry on all pre-disease performance without restriction, and 1 indicating some symptoms, but nearly fully ambulatory and able to carry out work of a light or sedentary nature.

      What Reasons Could Exclude Me from the Study?

      Here are the conditions under which you cannot take part in the study along with explanations for medical terms:

      1. Prior treatment with certain tyrosine kinase inhibitors (TKIs): If you have received treatment with drugs like pyrotinib, lapatinib, tucatinib, neratinib, and afatinib, which target the HER2 and/or epidermal growth factor receptor (EGFR), you may be excluded. Note that neratinib use is acceptable if given in an extended adjuvant setting, provided at least 12 months have elapsed since the last dose before starting the study drug.
      2. Inability to undergo contrast-enhanced MRI of the brain: Participants must be able to have an MRI with contrast to assess the brain.
      3. Symptomatic brain metastasis after CNS-directed local therapy: If you have had treatments aimed at brain metastases and still have symptoms, you cannot participate.
      4. Progression of brain metastases: If the brain metastases have progressed after starting the first line of treatment with trastuzumab, pertuzumab, and taxane, you are not eligible.
      5. Ongoing use of systemic corticosteroids: If you are taking more than 2 mg per day of dexamethasone (or an equivalent dose of another corticosteroid), you would be excluded from the study.
      6. Untreated brain lesions: If you have any brain lesions that have not been treated and could pose a risk.
      7. Known or suspected leptomeningeal disease (LMD): LMD refers to cancer that has spread to the membranes surrounding the brain and spinal cord.
      8. Poorly controlled seizures: If you experience more than one seizure per week, you may be excluded from the study.

      Remember, these are exclusion criteria specific to the clinical trial detailed in the file, and it’s important for your safety and the integrity of the trial results that these are strictly followed.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are as follows:

      1. Tucatinib (TUKYSA, ONT-380, ARRY-380): A tyrosine kinase inhibitor that targets the HER2/neu receptor. It is given at 300mg orally twice daily.
      2. Trastuzumab (Herceptin, Herceptin Hylecta): A monoclonal antibody that also targets the HER2/neu receptor. It can be administered as 6mg/kg intravenously (IV) or 600mg subcutaneously (SC) every 21 days.
      3. Pertuzumab (Perjeta): Another monoclonal antibody working against the HER2/neu receptor. The dosage is 420mg given by IV every 21 days.
      4. Combination product: Trastuzumab + Pertuzumab: This fixed-dose combination includes 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase, given subcutaneously every 21 days.

      All of these substances are designed to target the HER2/neu receptor, which is commonly overexpressed in certain types of breast cancer and contributes to the aggressive growth of tumors. By blocking this receptor, these drugs help slow the progression of cancer and may lead to better outcomes for patients.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial and their respective descriptions are:

      1. Tucatinib: Tucatinib is known in the medical literature and is an oral medication used to treat advanced unresectable or metastatic HER2-positive breast cancer. Other names for this substance include TUKYSA, ONT-380, and ARRY-380.
      2. Trastuzumab: Trastuzumab is a well-known medication in the field of medicine, used mostly for the treatment of HER2-positive breast cancer. It is administered intravenously or subcutaneously and is also known as Herceptin or Herceptin Hylecta.
      3. Pertuzumab: Pertuzumab is recognized in medical literature and is used in combination with other medications to treat HER2-positive breast cancer. It is given intravenously, and it is also known by the brand name Perjeta.
      4. Combination product: Trastuzumab + Pertuzumab: This combination product is administered subcutaneously and consists of pertuzumab, trastuzumab, and hyaluronidase. It may be used instead of trastuzumab and pertuzumab individually and is known as Phesgo.

      All of these substances are approved for clinical use and are widely recognized in medical practice and literature.


      Study ID

      CT-EU-00020727

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases