Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:23 AM
Study NCT ID:
NCT07480694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From enrollment to the last patient experiences disease progression or completes the 24-month follow-up.', 'description': 'the period from the start of eribulin mesylate-based therapy treatment until the disease progress or death from any cause, whichever occurred first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eribulin Mesylate-based Therapy, Advanced HER2-negative Breast Cancer, ADC'], 'conditions': ['Treatment Efficacy']}, 'descriptionModule': {'briefSummary': 'This study is a real-world study. we collected patients with advanced HER2-negative breast cancer previously treated with antibody-drug conjugates, and received eribulin mesylate-based therapy post-ADC. We retrospectively collect the data on previous systemic treatment, and prospectively collect the treatment data of the therapeutic regimens based on eribulin mesylate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced HER2-negative breast cancer patients previously treated with ADC', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 18 years old;\n2. Inoperable locally advanced or metastatic breast cancer;\n3. Planning to use a single-agent or combination treatment regimen based on eribulin;\n4. HER2 negative (IHC 0,+, or ++ but ISH negative);\n5. Previously received ADC treatment at the local advanced or metastatic disease stage;\n6. Previously received chemotherapy (including ADC) for local advanced or metastatic disease no more than 2 lines, where one treatment line is defined as completing at least one cycle of chemotherapy;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score (PS) 0-2;\n8. The investigators have evaluated that the patient's organ and bone marrow functions are suitable for medication use and there are no relevant contraindications;\n9. The subjects voluntarily join the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. HER2-positive tumors\n2. The hormone receptor status is unknown;\n3. Patients who have received eribulin treatment before;\n4. Those who have had other malignant tumors within the past 5 years (excluding the following situations: cured skin basal cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma; second primary cancer that has been cured and has no recurrence within 5 years; subjects who have clearly identified the origin of the metastatic lesion as being from a certain primary tumor);\n5. Mental illness or mental disorder, patients with poor compliance and inability to cooperate and describe treatment responses;\n6. Pregnant or lactating women;\n7. Other serious or uncontrollable diseases, or other conditions assessed by the researcher as not suitable for enrollment."}, 'identificationModule': {'nctId': 'NCT07480694', 'briefTitle': 'Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With ADC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Real-world Study of Eribulin Mesylate-based Therapy in Patients With Advanced HER2-negative Breast Cancer Previously Treated With Antibody-drug Conjugates', 'orgStudyIdInfo': {'id': 'EVALUATE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'advanced HER2-negative breast cancer patients previously treated with ADC'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jian Zhang', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '64175590'}], 'overallOfficials': [{'name': 'Jian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian Zhang,MD', 'investigatorAffiliation': 'Fudan University'}}}}