HER2-negative breast cancer
Conditions
Interventions
Triple-negative breast cancer (TNBC) previously treated with immune-checkpoint inhibitors (ICI).:Toripalimab+TPC
HR-positive/HER2-negative breast cancer:Toripalimab+TPC
TNBC without prior exposure to ICI.:Toripalimab+TPC
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with written informed consent and willingness to comply with study procedures and follow-up. 2.Age >= 18 years. 3.ECOG performance status = 3 months. 4.Histologically or cytologically confirmed HER2-negative breast cancer (HER2 negativity defined as one of the following: IHC 0, IHC 1+, or IHC 2+ with negative in-situ hybridization [ISH]). 5.Patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) must have experienced failure of at least one prior systemic line for recurrent/metastatic disease (recurrence = 12 months must have elapsed between ICI discontinuation and recurrence. • If ICI was given neoadjuvantly or for recurrent/metastatic disease, patients must have achieved clinical benefit (PR, CR, or SD > 24 weeks). b) Cohort B – ICI-naïve: no prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-stimulatory or checkpoint pathways. 6.For hormone-receptor–positive (HR+) disease: failure of >= 2 endocrine regimens in the recurrent/metastatic setting (unless investigator judges endocrine therapy non-beneficial) and failure of >=1 systemic chemotherapy for recurrence/metastasis (recurrence = 9 g/dL b. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L c. Platelets >= 100 × 10^9/L; Biochemistry: a. Total bilirubin ULN then direct bilirubin = 60 mL/min; 9.Within 7 days before first dose, women of child-bearing potential (WOCBP) must have a negative serum pregnancy test and agree to use effective contraception from study-drug initiation through 6 months after the last dose. WOCBP are defined as sexually mature females who: (1) have not undergone hysterectomy or bilateral oophorectomy, and (2) have not experienced natural amenorrhea for >= 24 consecutive months (post-cancer-therapy amenorrhea does not exclude fertility). Men with WOCBP partners must also agree to effective contraception during the same period.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled central nervous system metastases (defined as symptomatic or requiring corticosteroids or mannitol for symptom control). 2.History or presence of clinically significant or uncontrolled cardiac disease within 6 months before the first dose, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmias. 3.Malignancy within 5 years prior to the first dose (except adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix). 4.Active autoimmune disease requiring systemic therapy within 2 years before the first dose, except for vitiligo, type 1 diabetes mellitus, or residual hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy only. 5.Pleural effusion, pericardial effusion, or ascites that cannot be controlled with repeated drainage. 6.Known history of human immunodeficiency virus (HIV) infection. 7.Known history of hepatitis B or active hepatitis C virus infection. 8.Prior hypersensitivity to any component or excipient of the investigational products planned for administration. 9.Any other condition deemed by the investigator to be unsuitable for trial participation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Duration of remission;Overall survival;Progression-free survival;safety; | — |
Countries
China
Contacts
Public ContactYanmin
HenanCancerHospital
Outcome results
None listed