RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer
Age: Female, ≥18 years old and ≤70 years old.
Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with <1% positive tumor cells; PR-negative with <1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH/CISH without amplification).
Prior Treatment: Recurrent or metastatic refractory breast cancer with disease progression after prior immunotherapy.
Measurable Disease: At least one measurable lesion per RECIST v1.1 (≥20 mm by conventional CT or ≥10 mm by spiral CT; lesion must not have been previously irradiated).
Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).
CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.
Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.