Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 9:34 AM
Study NCT ID:
NCT06176534
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2023-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
Sponsor:
Organization:
Raw JSON
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The most recent pathological report of biopsy confirmed HR low expression and HER2 negative.\n\n 1. HR low expression was defined as 1-50% ER expression by immunohistochemistry (IHC); Or ER\\<1% and PR≥1%; Patients with ER expression of 1-10% or ER-/ PR-positive patients were eligible for inclusion after careful evaluation by the investigator, and those with a small tumor burden and candidates for endocrine therapy were eligible.\n 2. HER2-negative definition: IHC 0 or 1+; If the IHC was 2+, it was confirmed negative by fluorescence in situ hybridization (FISH).\n3. at least one measurable lesion;\n4. No previous salvage chemotherapy for metastatic disease was required, and first-line endocrine therapy was allowed;\n5. no previous CDK4/6 inhibitor; For adjuvant CDK4/6i treatment, recurrence and metastasis were required more than 1 year after drug withdrawal.\n6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, life expectancy is more than 12 weeks;\n7. Adequate function of major organs.\n8. All adverse events recovered to grade 1 or less before enrollment (NCI CTCAE version 5.0);\n9. patients without major organ dysfunction and heart disease;\n10. Women and men of childbearing potential must agree to use appropriate contraception before and during study participation.\n\nExclusion Criteria:\n\n1. symptomatic, uncontrolled brain or leptomeningeal metastases; Patients who had received previous systemic radical treatment for brain metastases (radiotherapy or surgery), if stable disease had been maintained for at least 1 month as confirmed by imaging, and if systemic hormone therapy (dose 10mg/ day prednisone or other effective hormones) for more than 2 weeks without clinical symptoms.\n2. patients received radiotherapy, chemotherapy, major surgery, targeted therapy or immunotherapy within 2 weeks before enrollment; Patients received endocrine therapy within 1 week before enrollment. Chemotherapy with nitrosourea or mitomycin was administered within 6 weeks before enrollment.\n3. participated in other clinical trials of new drugs within 4 weeks before enrollment;\n4. there can not be controlled by drainage or pneumatic methods third space effusion;\n5. patients with other malignant tumors within the past 3 years, excluding radical cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;\n6. suffering from serious or uncontrolled diseases, including but not limited to: 1) active viral infection, such as HIV or HBV active (HbsAg positive and HBV-DNA≥103, hepatitis C antibody positive); 2) history of severe cardiovascular disease: uncontrolled hypertension; Myocardial infarction, unstable arrhythmia, congestive heart failure, pericarditis, myocarditis, etc. Patients with NYHA class ⅲ-ⅳ cardiac dysfunction, or left ventricular ejection fraction (LVEF) 50% by echocardiography; 3) severe infection (e.g., intravenous antibiotic, antifungal, or antiviral therapy according to clinical practice) within 4 weeks prior to the first dose or unexplained fever during screening/before the first dose; 38.3°C (fever due to cancer, as judged by the investigator, was eligible);\n7. patients with a history of psychotropic drug abuse and unable to abstain or with mental disorders; Or accompanied by swallowing and absorption dysfunction;\n8. patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigators;\n9. patients with known history of allergy to the components of this regimen; A history of immunodeficiency, including testing positive for HIV, HCV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation;\n10. pregnant or lactating women;\n11. Patients deemed unsuitable for inclusion by the investigators.'}, 'identificationModule': {'nctId': 'NCT06176534', 'briefTitle': 'Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial', 'orgStudyIdInfo': {'id': 'HNCH-MBC013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'nab-paclitaxel 130mg/m2，day 1 and day 8 Capecitabine 2000mg/m2，from day1 to DAY 14 Vinorelbine 25mg/m2，day 1 and day 8', 'interventionNames': ['Drug: Experimental: chemotheyapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'palbociclib/Dalpiciclib Letrozole/Anastrozole/fulvestrant', 'interventionNames': ['Drug: Active Comparator: endocrine therapy']}], 'interventions': [{'name': 'Experimental: chemotheyapy', 'type': 'DRUG', 'otherNames': ['Vinorelbine 25mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2，from day1 to DAY 14'], 'description': 'nab-paclitaxel 130mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2, followed by nab-paclitaxel 130mg/m2，day 1 and day 8 or Capecitabine from day1 to DAY 14 Vinorelbine 25mg/m2，day 1 and day 8 + Capecitabine 2000mg/m2，from day1 to DAY 14', 'armGroupLabels': ['A']}, {'name': 'Active Comparator: endocrine therapy', 'type': 'DRUG', 'description': 'palbociclib 125mg per day for 21days Dalpiciclib 150mg per day for 21days Letrozole 2.5mg per day Anastrozole 1mg per day fulvestrant 500mg per 28 days', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan, Doctor', 'role': 'CONTACT', 'email': 'ym200678@126.com', 'phone': '+86 15713857388'}, {'name': 'Min Yan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Min Yan, M.D.', 'role': 'CONTACT', 'email': 'ym200678@126.com', 'phone': '+8615713857388'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Min Yan, MD', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}