A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
This study tests a combination of two drugs—all-trans retinoic acid (taken by mouth) and toripalimab (an immunotherapy)—to treat triple-negative breast cancer that has spread or returned after previous treatments. Researchers want to see if this combination is effective and safe for patients whose cancer no longer responds to standard therapies.
Key Objective:This trial is testing whether combining all-trans retinoic acid with an immunotherapy drug can improve survival and tumor control in advanced triple-negative breast cancer patients who have exhausted standard treatment options.
Who to Consider:Patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who have already tried at least two lines of previous therapy and are looking for additional treatment options should consider this trial.
Trial Parameters
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Brief Summary
To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years at the time of signing the informed consent form; 2. Pathologically confirmed as triple-negative breast cancer based on recent biopsy or other pathological specimens, with histological and/or cytological diagnosis; 3. Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least second-line standard treatment regimens; 4. According to RECIST 1.1, at least one measurable lesion is required. Patients with only skin lesions or bone lesions are not eligible for inclusion; 5. Adequate organ and bone marrow function (not received blood transfusions, recombinant human platelet growth factor, or colony-stimulating factor treatment in the 2 weeks before screening); 6. The subject voluntarily agrees to participate in this study, signs the informed consent form, and is able to comply with the visits and related procedures specified in the protocol. Exclusion Criteria: 1. Known symptomatic or uncontrolled brain