Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT06585969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614160', 'term': 'trastuzumab deruxtecan'}, {'id': 'C000589651', 'term': 'ribociclib'}, {'id': 'C000590451', 'term': 'abemaciclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 504}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'Up to 4 years after inclusion', 'description': 'Progression-free survival (ITT)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 4 years after inclusion', 'description': 'Overall survival in ITT cohort'}, {'measure': 'PFS by subtype', 'timeFrame': 'Up to 4 years after inclusion', 'description': 'PFS by subtype (Luminal B, HER2-enriched and Basal-like)'}, {'measure': 'OS by subtype', 'timeFrame': 'Up to 4 years after inclusion', 'description': 'OS by subtype (Luminal B, HER2-enriched and Basal-like)'}, {'measure': 'Quality of life', 'timeFrame': 'During treatment, estimated 18-24 months', 'description': 'Quality of life EORTC QLQ-C30/BR23 during treatment and at progression.'}, {'measure': 'Toxicity', 'timeFrame': 'During treatment, estimated 18-24 months', 'description': 'Toxicity on treatment (NCI-CTC v. 5.0)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer', 'ER-positive Breast Cancer', 'Luminal B', 'Her2 Enriched', 'Basal Like']}, 'descriptionModule': {'briefSummary': 'The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer', 'detailedDescription': "Study design and setting We will conduct an international, multicentre, open-label, randomised controlled trial. All oncological departments who treat patients with metastatic breast cancer can participate. The EU Clinical Trial Regulation will be applied.\n\nInterventions Trial participants will be randomised to trastuzumab deruxtecan or standard treatment.\n\nTrastuzumab deruxtecan\n\nPatients randomised to trastuzumab deruxtecan will be treated as:\n\nTrastuzumab deruxtecan until progression or intolerable toxicity, Trastuzumab deruxtecan: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.\n\nStandard\n\nPatients randomised to standard will be treated as:\n\nCDK4/6 inhibitor with an endocrine therapy until progression or intolerable toxicity CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 28 days cycle) or abemaciclib (150mg twice daily).\n\nEndocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)\n\nOther treatment Prophylactic antiemetics are allowed, including corticosteroids. Prophylactic antibiotics are allowed if deemed necessary for the patient. G-CSF is allowed when needed.\n\nAll other symptomatic treatment to perform best of care is allowed as long as name, administration and length is documented in the chart. Bone targeted agents are allowed. No other antineoplastic treatment is allowed.\n\nRadiological evaluation Patients will initially be scanned every 9-12 weeks as per investigator's or co-investigator's discretion with minimum a CT of the thorax and abdomen or a FDG-PET/CT. Patients with response can have this interval extended. Upon progression treatment/control is to be done according to department preferences, but subsequent treatment and day of death must be registered."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 or above.\n* Radiologically/pathologically verified metastatic breast cancer.\n* ER-positive (1% or more) and HER2-low (HER2 1+ or HER2 2+/ISH-neg)10,11.\n* PAM50 Luminal B, HER2-enriched or Basal-like.\n* Performance status 0-1.\n* Evaluable disease\n\nExclusion Criteria:\n\n* Patients who are incapable of understanding the written material received\n* Patients with inaccessible tumour tissue\n* Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)'}, 'identificationModule': {'nctId': 'NCT06585969', 'acronym': 'DISCORDANT', 'briefTitle': 'A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Danish Breast Cancer Cooperative Group'}, 'officialTitle': 'A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'DBCG-R25-DISCORDANT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trastuzumab-deruxtecan', 'description': 'Trastuzumab deruxtecan until progression or intolerable toxicity: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.', 'interventionNames': ['Drug: Trastuzumab deruxtecan (T-DXd)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immunohistochemistry guided treatment (standard)', 'description': "\\- CDK4/6 inhibitor with an endocrine therapy until progression og intolerable toxicity\n\n* CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 4 week schedule) or abemaciclib (125mg twice daily).\n* Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)", 'interventionNames': ['Drug: Ribociclib with ET', 'Drug: Abemaciclib with ET']}], 'interventions': [{'name': 'Trastuzumab deruxtecan (T-DXd)', 'type': 'DRUG', 'otherNames': ['Enhertu'], 'description': 'Trastuzumab deruxtexan every three weeks', 'armGroupLabels': ['Trastuzumab-deruxtecan']}, {'name': 'Ribociclib with ET', 'type': 'DRUG', 'description': 'Ribociclib with endocrine therapy', 'armGroupLabels': ['Immunohistochemistry guided treatment (standard)']}, {'name': 'Abemaciclib with ET', 'type': 'DRUG', 'description': 'Abemaciclib with endocrine therapy', 'armGroupLabels': ['Immunohistochemistry guided treatment (standard)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tobias Berg, MD', 'role': 'CONTACT', 'email': 'tobias.berg.01@regionh.dk', 'phone': '+45 38660669'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Breast Cancer Cooperative Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tobias Berg', 'investigatorAffiliation': 'Danish Breast Cancer Cooperative Group'}}}}