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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Paclitaxel Oral Solution (50mg/qd)
DrugPaclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.
Paclitaxel Oral Solution (100mg/TIW)
DrugPaclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Paclitaxel Oral Solution (OTD)
DrugOptimal tolerated dose (OTD) of metronomic paclitaxel oral solution.Each treatment cycle is 21 days.
Paclitaxel Oral Solution (150mg/TIW)
DrugPaclitaxel oral solution, 150 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Paclitaxel Oral Solution (200mg/TIW)
DrugPaclitaxel oral solution 200 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
Treatment groups
73 Participants
are divided into 5 treatment groupsGroup A: Metronomic Oral Paclitaxel 50 mg QDExperimental treatment 1 intervention
Group B: Metronomic Oral Paclitaxel 100 mg/d TIWExperimental treatment 1 intervention
Group C: Metronomic Oral Paclitaxel （OTD）Experimental treatment 1 intervention
Group D: Metronomic Oral Paclitaxel 150 mg/d TIWExperimental treatment 1 intervention
Group E: Metronomic Oral Paclitaxel 200 mg/d TIWExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
TRAE assessment: Within 7 days after the first dose DCR assessment: At the first efficacy evaluation (planned at 6 weeks after the first dose)2
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
Time frame
Up to approximately 24 months from the first dose of combination therapySponsors and contacts
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Source ClinicalTrials.gov