Clinical trial · Interventional
A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC
A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive. Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter. The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Sacituzumab Govitecan (SG) | Drug | Sacituzumab Govitecan | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SG plus Toripalimab
- description
- Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
- interventionNames
- Drug: Sacituzumab Govitecan (SG)
- Drug: Toripalimab
- type
- ACTIVE_COMPARATOR
- label
- Nab-Paclitaxel plus Toripalimab
- description
- Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
- interventionNames
- Drug: Toripalimab
- Drug: Nab-paclitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years. * Histologically or cytologically confirmed triple-negative breast cancer (TNBC). * Unresectable locally advanced or metastatic disease. * PD-L1 positive (CPS ≥1 as assessed by central laboratory). * No prior systemic treatment for advanced or metastatic TNBC. * Measurable disease per RECIST v1.1. * ECOG performance status of 0 or 1. * Adequate hematologic, hepatic, and renal function. * Willingness to provide informed consent. Exclusion Criteria: * Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies. * Known active central nervous system metastases. * Active autoimmune disease or history of autoimmune disorders requiring systemic treatment. * Active infection requiring systemic therapy. * Pregnancy or lactation. * Other active malignancies requiring treatment within the past 5 years. * History of severe hypersensitivity reactions to study drugs.
References
Publications (0)
Data not yet available