Actively Recruiting
A Multicohort Study of Toripalimab 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of toripalimab combined with chemotherapy chosen by the doctor in patients with advanced HER2-negative breast cancer who have not responded to previous treatments. The study is a phase 2 trial that includes different groups based on breast cancer types and prior treatment history, focusing on patients with triple-negative breast cancer and hormone receptor-positive disease. Participants receive toripalimab along with chemotherapy selected by their doctor. The study involves three groups: one with triple-negative breast cancer previously treated with immune-checkpoint inhibitors, one with triple-negative breast cancer without prior immune therapy, and one with hormone receptor-positive, HER2-negative breast cancer. Treatment is given during the main study period starting in January 2026. During the study, researchers will monitor tumor response every 8 weeks for the first 24 weeks and then every 12 weeks. They will also assess progression-free survival, disease control, duration of response, overall survival, and safety over up to 3 years. Participants will have regular visits for evaluations, including scans and lab tests. Safety will be tracked from consent until 30 days after the last treatment dose, with ongoing follow-up to understand the treatments' effects.
CONDITIONS
Brief 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...
- Voluntary participation with written informed consent and agreement to attend all follow-up visits
- Age 18 years or older
- ECOG performance status score of 1 or less and life expectancy of at least 3 months
- Histologically or cytologically confirmed HER2-negative breast cancer
- For unresectable locally advanced or metastatic triple-negative breast cancer: progression after at least one prior systemic treatment for recurrent/metastatic disease
- Cohort assignment based on prior immune-checkpoint inhibitor exposure for triple-negative breast cancer
- For hormone receptor-positive breast cancer: progression after at least two endocrine regimens and one systemic chemotherapy for recurrent/metastatic disease
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function as defined by specific hematology and serum chemistry criteria
- Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception
You will not qualify if you...
- Uncontrolled central nervous system metastases requiring symptom control
- Clinically significant or uncontrolled cardiac disease within 6 months before first dose
- Malignancy within 5 years before first dose except certain treated skin or cervical cancers
- Active autoimmune disease requiring systemic therapy within 2 years before first dose except specified conditions
- Uncontrolled pleural, pericardial, or ascitic fluid requiring repeated drainage
- Documented HIV infection
- Documented hepatitis B or active hepatitis C infection
- Prior hypersensitivity to any study drug components
- Any condition making the patient unsuitable for trial participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 8-week cycles within the first 24 weeks, then every 12 weeks until disease progression or discontinuation
Participants receive Toripalimab in combination with investigator-selected chemotherapy to treat advanced HER2-negative breast cancer.
Visits every 8 weeks within the first 24 weeks, then every 12 weeks
Duration - Up to 3 years
Participants are monitored for progression-free survival, duration of response, overall survival, and safety for up to 3 years after treatment.
Periodic visits during follow-up up to 3 years
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
M
Min Yan, Chief physician
M
Meng wei Zhang, Associate Chief Physician
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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