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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT07602907
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer
  • HER2-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel Oral Solution (50mg/qd) — DRUG
    Paclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.
  • Paclitaxel Oral Solution (100mg/TIW) — DRUG
    Paclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
  • Paclitaxel Oral Solution (OTD) — DRUG
    Optimal tolerated dose (OTD) of metronomic paclitaxel oral solution.Each treatment cycle is 21 days.
  • Paclitaxel Oral Solution (150mg/TIW) — DRUG
    Paclitaxel oral solution, 150 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
  • Paclitaxel Oral Solution (200mg/TIW) — DRUG
    Paclitaxel oral solution 200 mg orally three times weekly (TIW). Each treatment cycle is 21 days.

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Aug 20, 2029
Completion
Aug 20, 2029

Study Design

Enrollment
73 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metronomic Oral Paclitaxel 50 mg QD
  • Experimental: Metronomic Oral Paclitaxel 100 mg/d TIW
  • Experimental: Metronomic Oral Paclitaxel （OTD）
  • Experimental: Metronomic Oral Paclitaxel 150 mg/d TIW
  • Experimental: Metronomic Oral Paclitaxel 200 mg/d TIW

Primary Outcome Measure

Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel [ 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) ]

Central Contacts

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