The goal of this clinical trial is to learn if oral paclitaxel solution (metronomic scheduling) works to treat advanced HER2-negative breast cancer in adults. It will also learn about the safety of oral paclitaxel solution alone and combined with toripalimab.
The main questions it aims to answer are:
What is the optimal tolerated dose (OTD) of metronomic oral paclitaxel solution? Does metronomic oral paclitaxel plus toripalimab improve progression-free survival (PFS)? What medical problems do participants have when taking the study treatments? Researchers will evaluate metronomic oral paclitaxel alone (dose-finding) and metronomic oral paclitaxel plus toripalimab (expansion cohort) to see if the regimens work to treat advanced HER2-negative breast cancer.
Participants will:
Receive metronomic oral paclitaxel solution (one of two dose levels) once daily or three times weekly After OTD is determined, receive metronomic oral paclitaxel plus toripalimab every 3 weeks Visit the clinic regularly for safety checks, blood tests, and tumor imaging Keep records of treatment compliance and health-related quality of life
Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent/metastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.
Neoadjuvant or adjuvant therapy is not counted as a treatment line.
Disease recurrence >6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.
Disease recurrence >12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.
Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.
Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).
Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.
Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence/metastasis within 12 months after neoadjuvant/adjuvant therapy.