Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT05806060
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C490954', 'term': 'eribulin'}, {'id': 'C088832', 'term': 'CCDC6 protein, human'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)', 'description': 'time to progressive disease (according to RECIST1.1)'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'max 6 months', 'description': 'The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)'}, {'measure': 'DoR', 'timeFrame': 'max 6 months', 'description': 'Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.'}, {'measure': 'DCR', 'timeFrame': 'max 6 months', 'description': 'The percentage of subjects with CR+PR+SD and last more than 4 weeks in all of the participants with measurable lesions.'}, {'measure': 'OS', 'timeFrame': 'approximately 3 years', 'description': 'Time to death due to any cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple-Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': "The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ECOG Performance Status of 0-1\n* Expected lifetime of not less than three months\n* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype\n* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection\n* Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer\n* At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy\n* The functions of major organs are basically normal\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm\n* Have the cognitive ability to understand the protocol and be willing to participate and to be followed up\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing CNS metastases\n* Significant cardiovascular disease\n* Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception\n* Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access)\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma\n* Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs\n* Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites)\n* Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug\n* Long-term unhealing wound or incomplete healing of fracture\n* Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function\n* Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies\n* Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required\n* Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial\n* Urine protein ≥2+ and 24h urine protein quantitative \\> 1.0 g\n* Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \\>140mmHg, diastolic blood pressure \\>90mmHg)"}, 'identificationModule': {'nctId': 'NCT05806060', 'acronym': 'BCTOP-T-M01', 'briefTitle': 'Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'FUSCC-TNBC-BLIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'De novo or DFI≥12m Arm 1', 'description': 'If patients were De novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm, they would receive VEGFR BP102 with nab-palitaxel (Nab-P). And maintained by VEGFR and capecitabine if intolerable toxicity was observed with no progression.', 'interventionNames': ['Drug: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'De novo or DFI≥12m Arm 2', 'description': 'If patients were De novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm, they would receive nab-palitaxel (Nab-P). And maintained by capecitabine if intolerable toxicity was observed with no progression.', 'interventionNames': ['Drug: nab-paclitaxel, with maintenance of capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'DFI<12m Arm 1', 'description': "If patients' disease-free interval (DFI) were less than 12 months and were randomized to experimental arm, they would receive VEGFR BP102 with treatment of physician's choice (TPC).", 'interventionNames': ['Drug: VEGFR and TPC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DFI<12m Arm 2', 'description': "If patients' disease-free interval (DFI) were less than 12 months and were randomized to control arm, they would receive physician's choice (TPC).", 'interventionNames': ['Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1']}], 'interventions': [{'name': 'VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine', 'type': 'DRUG', 'otherNames': ['Bevacizumab (BP102)'], 'description': 'VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.', 'armGroupLabels': ['De novo or DFI≥12m Arm 1']}, {'name': 'nab-paclitaxel, with maintenance of capecitabine', 'type': 'DRUG', 'description': 'Nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.', 'armGroupLabels': ['De novo or DFI≥12m Arm 2']}, {'name': 'Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1', 'type': 'DRUG', 'description': 'TPC', 'armGroupLabels': ['DFI<12m Arm 2']}, {'name': 'VEGFR and TPC', 'type': 'DRUG', 'otherNames': ['Bevacizumab (BP102)'], 'description': 'VEGFR bevacizumab and TPC', 'armGroupLabels': ['DFI<12m Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-Ming Shao, MD', 'role': 'CONTACT', 'email': 'zhimingshao@yahoo.com', 'phone': '86-21-641755901105'}, {'name': 'Lei Fan, MD', 'role': 'CONTACT', 'email': 'cmchen@medmail.com.cn', 'phone': '86-21-641755901105'}, {'name': 'Zhi-Ming Shao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Min He, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Linxiaoxi Ma, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ying Zhou', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Breast cancer institute of Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhimin Shao', 'role': 'CONTACT', 'email': 'zhimingshao@yahoo.com', 'phone': '86-021-64175590', 'phoneExt': '8888'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhimin Shao', 'investigatorAffiliation': 'Fudan University'}}}}