Clinical trial · Interventional
Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
A Randomized, Double-Blind, Multicenter, Phase III Study of Toripalimab(JS001) in Combination With Nab-Paclitaxel Versus Placebo Plus Nab-Paclitaxel for Patients With Metastatic or Recurrent Triple-Negative Breast Cancer With or Without Systemic Treatment (TORCHLIGHT)
- 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 multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).
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 Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS001 | Drug | Toripalimab | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JS001 Plus Nab-Paclitaxel
- description
- Patients will receive both JS001 and Nab-Paclitaxel.
- interventionNames
- Drug: JS001
- Drug: Nab-Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Placebo Plus Nab-Paclitaxel
- description
- Patients will receive both placebo and Nab-Paclitaxel.
- interventionNames
- Drug: Placebo
- Drug: Nab-Paclitaxel
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intend to Treat patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Metastatic or recurrent triple negative breast cancer (TNBC); * Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-); * Eligible for taxane monotherapy; * No more than one line of chemotherapy in metastatic setting; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Life expectancy of 12 weeks or more; * At least one measurable lesion per RECIST v1.1; * Demonstrate adequate hematologic and organ functions as defined in the protocol Exclusion Criteria: Prior treatment with taxane as first line treatment; * Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) * MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study; * Meningeal carcinomatosis; * Pregnancy or lactation; * Active hepatitis B or hepatitis C.
References
Publications (0)
Data not yet available