NCT07040644Not yet recruitingPhase 2
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 · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- NCT number
- NCT07040644
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From 1 Sept 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
Other illness
- Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
- Active infection requiring systemic therapy.
- Other active malignancies requiring treatment within the past 5 years.
- History of severe hypersensitivity reactions to study drugs.
Other
- Known active central nervous system metastases.
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat Sen Memorial Hospital of Sun Yat sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.