Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:00 AM
Study NCT ID:
NCT07359404
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-22
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608132', 'term': 'sacituzumab govitecan'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trop-2 Expression Level', 'timeFrame': 'From baseline up to approximately 32 months', 'description': 'Assessment of Trop-2 expression in tumor tissue using Immunohistochemistry (IHC). Results are reported as Histochemical Score (H-score, ranging from 0 to 300). This measure will be analyzed to explore the association with efficacy outcomes (PFS, ORR).'}, {'measure': 'UGT1A1 Genotype Status', 'timeFrame': 'From baseline up to approximately 32 months', 'description': 'Assessment of UGT1A1 gene polymorphisms (e.g., 1, 28 alleles) in blood or tissue samples using PCR or sequencing. Results are categorized by genotype (e.g., homozygous wild-type, heterozygous, homozygous mutant). This measure will be analyzed to explore the association with safety outcomes (adverse events).'}], 'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'From start of treatment until disease progression or death, assessed up to approximately 32 months (based on study completion date of Dec 2026)'}, {'measure': 'Incidence and Severity of Adverse Events (Safety)', 'timeFrame': 'From start of treatment through 90 days after the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'From start of treatment until disease progression or intolerance, assessed every 2 cycles, assessed up to approximately 32 months'}, {'measure': 'Overall Survival', 'timeFrame': 'From start of treatment until death, assessed up to approximately 32 months'}, {'measure': 'Disease Control Rate', 'timeFrame': 'From start of treatment until disease progression or intolerance, assessed up to approximately 32 months'}, {'measure': 'Duration of Response', 'timeFrame': 'From date of first response until disease progression or death,assessed up to approximately 32 months'}, {'measure': '6-month Progression-Free Survival Rate', 'timeFrame': 'At 6 months after treatment initiation'}, {'measure': '6-month Overall Survival Rate', 'timeFrame': 'At 6 months after treatment initiation'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, multicenter, Phase II clinical study aiming to explore the efficacy and safety of Sacituzumab Govitecan combined with Bevacizumab as a second-line or later treatment for patients with metastatic triple-negative breast cancer (mTNBC). The study will be conducted in 6-8 centers in China.\n\nThe study is divided into two phases: a Safety Run-in Phase and a Dose Expansion Phase.\n\nIn the Safety Run-in Phase (3-12 patients), three dose levels are planned to determine the recommended dose. The starting dose (Level 1) is Sacituzumab Govitecan 10 mg/kg (Days 1, 8) plus Bevacizumab 7.5 mg/kg (Day 1) every 21 days. Based on the occurrence of Dose-Limiting Toxicities (DLT) in the first cycle, the Safety Monitoring Committee (SMC) will decide whether to continue the current dose or de-escalate to Level 2 (Sacituzumab Govitecan 10 mg/kg + Bevacizumab 5 mg/kg) or Level 3 (Sacituzumab Govitecan 7.5 mg/kg + Bevacizumab 5 mg/kg).\n\nIn the Dose Expansion Phase, 40-50 patients will be enrolled to receive the combination therapy at the recommended dose determined in the run-in phase. Efficacy will be evaluated every 2 cycles according to RECIST 1.1, and safety will be assessed continuously until disease progression or intolerable toxicity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged \\> 18 years.\n2. Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).\n3. ER and PR negativity is defined as \\< 10% expression in tumor cells. HER2 negativity is defined as IHC 0, 1+, or IHC 2+ with FISH negative. Must have received at least one prior systemic therapy in the metastatic setting.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy of more than 3 months.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ function.\n8. Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)\n\nExclusion Criteria:\n\n1. Prior treatment with Sacituzumab Govitecan or Bevacizumab.\n2. Uncontrolled central nerve\n3. Presence of other primary malignancies.\n4. Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.'}, 'identificationModule': {'nctId': 'NCT07359404', 'briefTitle': 'Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'Y-Gilead2024-PT-0284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacituzumab Govitecan + Bevacizumab', 'interventionNames': ['Drug: Sacituzumab Govitecan (SG)', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Sacituzumab Govitecan (SG)', 'type': 'DRUG', 'description': 'Administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle. In the Safety Run-in phase, the starting dose is 10 mg/kg, with a potential de-escalation to 7.5 mg/kg based on Dose-Limiting Toxicity (DLT). In the Expansion phase, patients receive the determined recommended dose', 'armGroupLabels': ['Sacituzumab Govitecan + Bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Administered by intravenous infusion on the first day of each 21-day cycle. In the safety trial phase, the starting dose is 7.5 mg/kg and can be reduced to 5 mg/kg depending on dose-limiting toxicity (DLT). During the expansion phase, patients receive the determined recommended dose', 'armGroupLabels': ['Sacituzumab Govitecan + Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'YING FAN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'YING FAN', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}