NCT07359404Enrolling by invitationPhase 2
Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC
A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- YING FAN
- NCT number
- NCT07359404
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Apr 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with Sacituzumab Govitecan or Bevacizumab.
Other illness
- Presence of other primary malignancies.
- Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.
Other
- Uncontrolled central nerve
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.