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

NCT07602907 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-08-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Paclitaxel Oral Solution (50mg/qd)

Paclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.

DRUG

Paclitaxel Oral Solution (100mg/TIW)

Paclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.

DRUG

Paclitaxel Oral Solution (OTD)

Optimal tolerated dose (OTD) of metronomic paclitaxel oral solution.Each treatment cycle is 21 days.

DRUG

Paclitaxel Oral Solution (150mg/TIW)

Paclitaxel oral solution, 150 mg orally three times weekly (TIW). Each treatment cycle is 21 days.

DRUG

Paclitaxel Oral Solution (200mg/TIW)

Paclitaxel oral solution 200 mg orally three times weekly (TIW). Each treatment cycle is 21 days.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-04
Primary Completion
2029-08-20
Completion
2029-08-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602907 on ClinicalTrials.gov