Clinical trial · Observational
Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration
A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy
- 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)
The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer. The main questions it aims to answer are: 1. To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer. 2. To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer. Participants will: Have their progression - free survival (PFS) observed and evaluated. Have all adverse events and immune - related adverse events monitored to assess safety. Have their objective response rate measured as a secondary outcome. Have their survival period tracked as a secondary outcome. Have biomarkers associated with efficacy observed and explored as a secondary outcome.
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 |
|---|---|---|---|
| TNBC | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sacituzumab Govitecan (SG)+Toripalimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sacituzumab govitecan combined with Toripalimab
- interventionNames
- Drug: Sacituzumab Govitecan (SG)+Toripalimab
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- timeFrame
- Enrollment up for approximately 36 months.
- description
- PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
Secondary outcomes (4)
- measure
- Overall Survival (OS)
- timeFrame
- Enrollment up for approximately 53 months.
- description
- OS is defined as the time from the date of randomization until death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female breast cancer patients aged 18 to 75 years old; 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1; 3. Patients with histologically or cytologically confirmed advanced triple-negative breast cancer; 4. Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer; 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion; 6. Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab. Exclusion Criteria: 1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention; 2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy; 3. Patients who have previously used or are currently using PD-(L)1 inhibitors and/or ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors; 4. Patients who are considered by the investigator to be unsuitable for participating in this study.
References
Publications (0)
Data not yet available