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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Sacituzumab Govitecan (SG); Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Cancer hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged > 18 years.
2. Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy of more than 3 months.
6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
7. Adequate organ function.
8. Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)

Exclusion Criteria:

1. Prior treatment with Sacituzumab Govitecan or Bevacizumab.
2. Uncontrolled central nerve
3. Presence of other primary malignancies.
4. Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sacituzumab Govitecan + Bevacizumab

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival	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)	From start of treatment through 90 days after the last dose of study drug.

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	From start of treatment until disease progression or intolerance, assessed every 2 cycles, assessed up to approximately 32 months
Overall Survival	From start of treatment until death, assessed up to approximately 32 months
Disease Control Rate	From start of treatment until disease progression or intolerance, assessed up to approximately 32 months
Duration of Response	From date of first response until disease progression or death,assessed up to approximately 32 months
6-month Progression-Free Survival Rate	At 6 months after treatment initiation
6-month Overall Survival Rate	At 6 months after treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	From baseline up to approximately 32 months

Collaborators and Investigators

• Sponsor: YING FAN

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; sacituzumab govitecan
• Other Study ID Numbers: Y-Gilead2024-PT-0284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No