Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital
About this trial
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.
The main questions this study aims to answer are:
What doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?
This study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.
Participants will:
Receive metronomic oral paclitaxel solution according to the assigned dose schedule.
Visit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.
Complete assessments of treatment response, side effects, and quality of life during the study.
Continue follow-up after treatment to collect information about disease status and survival.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Paclitaxel Oral Solution (50mg/qd)
- Paclitaxel Oral Solution (100mg/TIW)
- Paclitaxel Oral Solution (OTD)
- Paclitaxel Oral Solution (150mg/TIW)
- Paclitaxel Oral Solution (200mg/TIW)
Treatment groups
73 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov