Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacituzumab Govitecan (SG), Bevacizumab.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer
Overview
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.
Interventions
- Drug Sacituzumab Govitecan (SG)
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 - Drug Bevacizumab
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
Primary outcome measures
- 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.]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07359404 · Y-Gilead2024-PT-0284