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Enrolling by Invitation

NCT Number: NCT07359404

Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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)

  2. Incidence and Severity of Adverse Events (Safety)

    Time frame: From start of treatment through 90 days after the last dose of study drug.

Secondary outcomes

  1. Objective Response Rate

    Time frame: From start of treatment until disease progression or intolerance, assessed every 2 cycles, assessed up to approximately 32 months

  2. Overall Survival

    Time frame: From start of treatment until death, assessed up to approximately 32 months

  3. Disease Control Rate

    Time frame: From start of treatment until disease progression or intolerance, assessed up to approximately 32 months

  4. Duration of Response

    Time frame: From date of first response until disease progression or death,assessed up to approximately 32 months

  5. 6-month Progression-Free Survival Rate

    Time frame: At 6 months after treatment initiation

  6. 6-month Overall Survival Rate

    Time frame: At 6 months after treatment initiation

Other outcomes

  1. Trop-2 Expression Level

    Time frame: From baseline up to approximately 32 months

    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).

  2. UGT1A1 Genotype Status

    Time frame: From baseline up to approximately 32 months

    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).

Sponsors and collaborators

Lead sponsor

YING FAN

Other

Registry information

Official study title

A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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