Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT04220203
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-06-26
First Post:
2020-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000705452', 'term': 'tucatinib'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['HER2-positive Breast Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this program is to provide access to tucatinib in the United States before FDA approval.\n\nParticipants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle.\n\nTo learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by ISH or FISH or IHC methodology\n* For patients WITHOUT presence or history of brain metastases, have received previous treatment with trastuzumab, pertuzumab, and T-DM1\n* For patients WITH presence or history of brain metastases, have received previous treatment with trastuzumab\n* Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by treating physician), or be intolerant of last systemic therapy\n* Have measurable disease or non-measurable disease assessable by standard of care imaging methods\n* Have ECOG PS 0 or 1\n* Have a life expectancy of at least 6 months, in the opinion of the treating physician\n\nExclusion Criteria:\n\n* Eligible for a tucatinib clinical trial\n* Disease recurrence within 3 months of last capecitabine for metastatic disease\n* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the protocol drugs\n* Have received treatment with any systemic anti-cancer therapy (excluding hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of protocol treatment or are currently participating in an interventional clinical trial. Have received hormonal therapies \\<1 week of the first dose of protocol treatment.\n* Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:\n\n * Alopecia and neuropathy, which must have resolved to ≤ Grade 2\n * CHF, which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely\n * Anemia, which must have resolved to ≤ Grade 2\n* Have clinically significant cardiopulmonary disease\n* Have known myocardial infarction or unstable angina within 6 months prior to first dose of protocol treatment\n* Are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease with uncontrolled disease\n* Are known to be positive for HIV with uncontrolled disease\n* Are pregnant, breastfeeding, or planning a pregnancy\n* Require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed)\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a CYP2C8 or CYP3A4 inducer within 5 day prior to start of tucatinib treatment.\n* Have known dihydropyrimidine dehydrogenase deficiency\n* Have evidence within 2 years of the start of protocol treatment of another malignancy that required systemic treatment.\n\nCNS Exclusion - patients must not have any of the following:\n\n* Any untreated brain lesions \\> 2.0 cm in size, unless discussed with medical monitor and approval for enrollment is given\n* Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\> 2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of ≤ 2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the medical monitor\n* Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).\n* Known or suspected LMD as documented by the treating physician\n* Have poorly controlled (\\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy'}, 'identificationModule': {'nctId': 'NCT04220203', 'briefTitle': 'Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seagen Inc.'}, 'officialTitle': 'A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma', 'orgStudyIdInfo': {'id': 'SGNTUC-021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tucatinib', 'type': 'DRUG', 'description': '300 mg orally two times per day'}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': '1000 mg/m\\^2 orally two times per day on Days 1-14 of each 21-day cycle'}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seagen, a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}