A Phase 2 interventional study of Sacituzumab Govitecan (SG) and Bevacizumab in Advanced Breast Cancer, sponsored by YING FAN. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by YING FAN · Phase 2, Interventional, and Treatment
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.
The study is divided into two phases: a Safety Run-in Phase and a Dose Expansion Phase.
In 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).
In 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.
This is the only study on the registry with YING FAN as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sacituzumab Govitecan (SG) · Drug: Bevacizumab
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
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
Progression-Free Survival
Time frame: From start of treatment until disease progression or death, assessed up to approximately 32 months (based on study completion date of Dec 2026)
Incidence and Severity of Adverse Events (Safety)
Time frame: From start of treatment through 90 days after the last dose of study drug.
Objective Response Rate
Time frame: From start of treatment until disease progression or intolerance, assessed every 2 cycles, assessed up to approximately 32 months
Overall Survival
Time frame: From start of treatment until death, assessed up to approximately 32 months
Disease Control Rate
Time frame: From start of treatment until disease progression or intolerance, assessed up to approximately 32 months
Duration of Response
Time frame: From date of first response until disease progression or death,assessed up to approximately 32 months
6-month Progression-Free Survival Rate
Time frame: At 6 months after treatment initiation
6-month Overall Survival Rate
Time frame: At 6 months after treatment initiation
Trop-2 Expression Level
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).
Time frame: From baseline up to approximately 32 months
UGT1A1 Genotype Status
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).
Time frame: From baseline up to approximately 32 months
Plan to share: No
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