Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC

NCT07359404 | Enrolling By Invitation Phase 2

• 1 other identifier: Y-Gilead2024-PT-0284
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Other Outcomes (2)

• Trop-2 Expression Level

  From baseline up to approximately 32 months

• UGT1A1 Genotype Status

  From baseline up to approximately 32 months

Study Arms (1)

Sacituzumab Govitecan + Bevacizumab

EXPERIMENTAL

Drug: Sacituzumab Govitecan (SG); Drug: Bevacizumab

Interventions

Sacituzumab Govitecan (SG) DRUG

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

Sacituzumab Govitecan + Bevacizumab

Bevacizumab DRUG

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

Sacituzumab Govitecan + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• YING FAN: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

sacituzumab govitecan; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 22, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)