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

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.

NCT Number	NCT07602907
Lead Sponsor	Zhejiang Cancer Hospital
Conditions	Advanced Breast Cancer, HER2-negative Breast Cancer
Enrollment	73 participants
Start Date	2026-08-04
Primary Completion	2029-08-20 (estimated)
Study Completion	2029-08-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-11