Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-19 @ 3:10 AM
Study NCT ID:
NCT05731258
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2032-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2023-02-07', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac safety', 'timeFrame': '10 years', 'description': 'Cardiac ejection fraction'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Liposomal Doxorubicin', 'Efficacy', 'Safety', 'Postoperative Adjuvant Treatment']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, aged 18-75 years;\n2. Primary breast cancer diagnosed histopathologically;\n3. Adjuvant chemotherapy regimens include liposomal doxorubicin;\n4. ECoG PS score: 0-1 points;\n5. Left ventricular ejection fraction (LVEF) ≥ 55%;\n6. Estimated survival ≥ 6 months;\n7. Major organ function is normal, i.e. meets the following criteria:\n\n ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L；② Platelets ≥ 100 × 10 9 /L；③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5\n\n × ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；\n8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Pregnant, lactating patients;\n2. Breast cancer has been found to have distant metastasis;\n3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;\n4. Those with severe infection or active peptic ulcer requiring treatment;\n5. Allergic to chemotherapy drugs;\n6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;\n7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;\n8. Patients who are participating in other clinical trials or within a month.'}, 'identificationModule': {'nctId': 'NCT05731258', 'briefTitle': 'Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen', 'orgStudyIdInfo': {'id': '2022-0239'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Liposomal doxorubicin containing regimen', 'type': 'DRUG', 'description': 'Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaochen Wang, Dr.', 'role': 'CONTACT', 'email': 'wangxiaochen@zju.edu.cn', 'phone': '+86 13958161286'}, {'name': 'Shizhen Zhang, Dr.', 'role': 'CONTACT', 'email': 'zhangshizhen@zju.edu.cn', 'phone': '+86 15168338547'}], 'facility': 'Second Affiliate Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaochen Wang, Dr.', 'role': 'CONTACT', 'email': 'wangxiaochen@zju.edu.cn', 'phone': '+86 13958161286'}, {'name': 'Shizhen Zhang, Dr.', 'role': 'CONTACT', 'email': 'zhangshizhen@zju.edu.cn', 'phone': '+86 15168338547'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}