NCT04389073

Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine

Status unknown Phase 2 Last updated 25 February 2022

What this trial tests

Phase 2 trial testing Vinorelbine 40mg in Metastatic Breast Cancer in 138 participants. Status unknown.

Timeline

1 April 2020

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	138
Start date	1 April 2020
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	2 locations across China

Drugs / interventions tested

• Vinorelbine 40mg
• Toripalimab 240mg — full drug profile →
• Bevacizumab 5 mg/kg
• Cyclophosphamide 50 mg — full drug profile →
• Capecitabine 500Mg Oral Tablet — full drug profile →
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and active the immune response of these patients. The combination of Toripalimab and Vinorelbine would provide a higher gain in anti-tumor response in these patients than in those with chemotherapy alone.

The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2- patients with metastatic breast cancer, aiming to evaluate the clinical activity of the combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine (40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously \[IV\]). The adverse events of the two drugs are well known.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metronomic chemotherapy and drug repurposing: A paradigm shift in oncology.
   Jan N, Sofi S, Qayoom H, Shabir A, et al · · 2024 · cited 26× · PMID 38314272 · DOI 10.1016/j.heliyon.2024.e24670
2. Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial.
   Mo H, Yu Y, Sun X, Ge H, et al · · 2024 · cited 23× · PMID 38969879 · DOI 10.1038/s41591-024-03088-2
3. Current Research Status of Metronomic Chemotherapy in Combination Treatment of Breast Cancer.
   Liu J, He M, Wang Z, Li Q, et al · · 2022 · cited 17× · PMID 35988534 · DOI 10.1159/000526481
4. Immunotherapy in breast cancer: current landscape and emerging trends.
   Ran R, Chen X, Yang J, Xu B. · · 2025 · cited 16× · PMID 40405250 · DOI 10.1186/s40164-025-00667-y
5. Predictive circulating biomarkers of the response to anti-PD-1 immunotherapy in advanced HER2 negative breast cancer.
   Wei Y, Ge H, Qi Y, Zeng C, et al · · 2025 · cited 4× · PMID 40000397 · DOI 10.1002/ctm2.70255
6. Effects of the Alkylating Agent Cyclophosphamide in Potentiating Anti-Tumor Immunity.
   Gephart BD, Coulter DW, Solheim JC. · · 2025 · cited 2× · PMID 40650216 · DOI 10.3390/ijms26136440
7. An immunogenic cell death-related signature for prediction of prognosis and response to immunotherapy in breast cancer.
   Li C, Guo F, Zhai J, Liu X, et al · · 2024 · cited 2× · PMID 37989550 · DOI 10.1097/cm9.0000000000002862
8. Bispecific Antibodies in Breast Cancer Immunotherapy: Mechanisms, Advances, and Translational Challenges.
   Brogna MR, Ferrara G, Varone V, Montone A, et al · · 2026 · PMID 41637006 · DOI 10.1007/s11523-026-01198-0