Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-26 @ 3:25 PM
Study NCT ID:
NCT05728268
Status:
UNKNOWN
Last Update Posted:
2023-02-15
First Post:
2023-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2023-02-04', 'studyFirstSubmitQcDate': '2023-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RCB', 'timeFrame': '7 days', 'description': 'Residual Cancer Burden'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with age of 18 to 70 years old.\n* Newly diagnosed breast cancer patients.\n* Planned neoadjuvant chemotherapy.\n* Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.\n* HER2/neu-negative.\n* Ki67≥30%.\n* Clinical stage IIB-IIIC.\n* Informed consent form understood and signed.\n* Patient agrees to all follow-up visits.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Women of childbearing potential must have a negative serum pregnancy test.\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy.\n* Nursing mothers.\n* Active or uncontrolled infection.\n* Presence of another malignancies.\n* Granulocyte count \\< 1.5\\*10\\^9/L.\n* Platelet count \\< 100\\*10\\^9/L.\n* Hemoglobin \\< 90g/L.\n* Serum Creatinine more than 1.5 upper limit.\n* AST and ALT more than 2.5 upper limit.\n* LVEF\\< 50%.'}, 'identificationModule': {'nctId': 'NCT05728268', 'briefTitle': 'Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index', 'organization': {'class': 'OTHER', 'fullName': 'Shantou Central Hospital'}, 'officialTitle': 'Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index', 'orgStudyIdInfo': {'id': 'ShantouCH02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose-dense arm', 'interventionNames': ['Drug: dose-dense nab-paclitaxel followed by EC']}], 'interventions': [{'name': 'dose-dense nab-paclitaxel followed by EC', 'type': 'DRUG', 'description': 'dose-dense nab-paclitaxel followed by EC', 'armGroupLabels': ['dose-dense arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haitong Lyu', 'role': 'CONTACT', 'email': 'heton25@foxmali.com', 'phone': '+8613631403739'}], 'facility': 'Shantou Central Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shantou Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Zhiyong Wu', 'investigatorAffiliation': 'Shantou Central Hospital'}}}}