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.
Parallel
Paclitaxel Oral Solution
DrugPaclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.
Paclitaxel Oral Solution
DrugPaclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Toripalimab
DrugOptimal tolerated dose (OTD) of metronomic paclitaxel oral solution plus toripalimab 240 mg intravenously on day 1 of each 21-day cycle.
Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel
To evaluate the safety, tolerability, and Disease Control Rate (DCR) of different doses of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer, and select the Optimal Tolerated Dose (OTD) for subsequent combination therapy.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first administration of combination therapy to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
