Actively Recruiting
A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer
Led by Henan Cancer Hospital · Updated on 2026-04-20
92
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.
CONDITIONS
Official Title
A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older
- Must voluntarily agree to participate and provide written informed consent
- Must have an ECOG performance-status score of 0 or 1 and a life expectancy of at least 3 months
- Histologically or cytologically confirmed HER2-negative breast cancer (IHC 0, 1+, or 2+ with negative ISH)
- For triple-negative breast cancer: progression after at least one prior systemic treatment for recurrent/metastatic disease; specific cohort assignment based on prior immune checkpoint inhibitor exposure
- For hormone-receptor-positive breast cancer: progression after at least two prior endocrine therapies and at least one prior systemic chemotherapy for recurrent/metastatic disease
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function including specified blood counts and liver and kidney function
- Women of child-bearing potential must have a negative pregnancy test before first dose and use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Uncontrolled brain metastases requiring corticosteroids or mannitol
- Significant or uncontrolled heart disease within 6 months before treatment
- Cancer diagnosed within 5 years before treatment except certain skin or cervical cancers
- Active autoimmune disease needing systemic therapy within 2 years except specified conditions
- Uncontrolled fluid buildup requiring repeated drainage
- HIV infection
- Hepatitis B or active hepatitis C infection
- Known allergy to study drug components
- Any condition the investigator deems unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
M
Min Yan, Chief physician
CONTACT
M
Meng wei Zhang, Associate Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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