Klinische Studie
Eine randomisierte, doppelblinde Phase-3-Studie mit Tucatinib oder Placebo in Kombination mit Trastuzumab und Pertuzumab als Erhaltungstherapie bei metastasiertem HER2+-Brustkrebs (Seagen)(HER2CLIMB-05)Eine randomisierte, doppelblinde Phase-3-Studie mit Tucatinib oder Placebo in Kombination mit Trastuzumab und Pertuzumab als Erhaltungstherapie bei metastasiertem HER2+-Brustkrebs
Krankheitsentität(en)
Brust
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien- Have centrally confirmed HER2+ breast carcinoma per 2018 American Society of Clinical Oncologists (ASCO)-College of American Pathologists (CAP) guidelines. Tissue blocks or slides must be submitted and confirmed as HER2+ by a sponsor-designated central laboratory prior to randomization
- Have unresectable locally advanced or metastatic (hereafter referred to as “advanced”) disease; if recurrent (after [neo]adjuvant therapy), there must be a minimum 6-month treatment-free interval from any trastuzumab or pertuzumab received in the early breast cancer setting to the diagnosis of advanced HER2+ disease. Prior standard of care therapy for early breast cancer is permitted (eg, prior ado-trastuzumab emtansine [T-DM1]); however, Exclusion Criterion 1 should be noted.
- Have received 4-8 cycles (21-day cycles) of previous treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression (per investigator judgement)
- Known hormone receptor status (per local guidelines; may be hormone receptor positive [HR+] or negative [HR-])
- Be at least 18 years of age, and legally an adult at time of consent
Wesentliche Ausschlusskriterien- Have previously been treated with any anti-HER2 and/or anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor including pyrotinib, lapatinib, tucatinib, neratinib, and afatinib (except neratinib if given in the extended adjuvant setting and at least 12 months have elapsed from the last neratinib dose to the start of study drug) or are currently participating in another interventional clinical Trial
- Unable for any reason to undergo contrast MRI of the brain
- History of allergic reactions to trastuzumab, pertuzumab, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion-related reactions to trastuzumab that were successfully managed, known allergy to one of the excipients in the study drugs, or hypersensitivity to murine proteins
- Are positive for Hepatitis B by surface antigen expression, positive for Hepatitis C infection, or the presence of known chronic liver disease. Subjects who have been treated for Hepatitis C infection are permitted if they have documented sustained virologic response of at least 12 weeks. The latest local guidelines should be followed regarding the testing of Hepatitis B DNA levels by polymerase chain reaction (PCR).Subjects with Hepatitis B DNA levels by PCR that require nucleoside analogue or other therapies are not eligible for the trial.
- Are pregnant, breastfeeding, or planning a pregnancy from time of informed consent until 7 months after the final dose of study drug
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823403fhk-studienzentrum(at)csj.de