Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC

Plain-language summary

This study evaluates the combination of Sacituzumab Govitecan (SG) and Bevacizumab for the treatment of metastatic triple-negative breast cancer (TNBC). Patients over 18 with recurrent or metastatic TNBC who have already received at least one systemic therapy in the metastatic setting can take part. The study is being conducted in Phase 2 and is enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Enrolling by invitation

Sponsor

YING FAN

Intervention

Sacituzumab Govitecan (SG), Bevacizumab

Start date

4/1/2024

Estimated completion

12/31/2026

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.