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Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later May 7, 2029 → Aug 20, 2029
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Zhejiang Cancer Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv2 Show 8 more changesShow less
    • Recruitment opened
    • Enrollment increased: 44 → 73 participants
    • Start date: May 30, 2026 to Aug 4, 2026
    • Primary and study completion pushed from May 7, 2029 to Aug 20, 2029
    • Trial arms changed: 3 → 5
    • Study sites: 0 to 1
    • Interventions: Paclitaxel Oral Solution (Drug), Paclitaxel Oral Solution (Drug), Toripalimab (Drug) to Paclitaxel Oral Solution (100mg/TIW) (Drug), Paclitaxel Oral Solution (150mg/TIW) (Drug), Paclitaxel Oral Solution (200mg/TIW) (Drug)…
    • Study title shortened, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07602907
Lead Sponsor Zhejiang Cancer Hospital
Conditions
(from sponsor)		 Advanced Breast Cancer, HER2-negative Breast Cancer
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov