Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC
Enrolling by invitation · Phase 2
Conditions studied: Advanced Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07359404
- Run by
- YING FAN
- People needed
- 60
- Starts
- 2024-04-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged > 18 years.
- Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of more than 3 months.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function.
- Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)
You may not qualify if…
- Prior treatment with Sacituzumab Govitecan or Bevacizumab.
- Uncontrolled central nerve
- Presence of other primary malignancies.
- Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.
Where it is running
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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