Metronomic Oral Paclitaxel Monotherapy and Combined Immunotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose Exploration and Expansion Trial

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT07602907
Phase
PHASE2
Status
Not Yet 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 — DRUG
    Paclitaxel oral solution, 50 mg orally once daily (QD), continuously administered. Each treatment cycle is 21 days.
  • Paclitaxel Oral Solution — DRUG
    Paclitaxel oral solution, 100 mg orally three times weekly (TIW). Each treatment cycle is 21 days.
  • Toripalimab — DRUG
    Optimal tolerated dose (OTD) of metronomic paclitaxel oral solution plus toripalimab 240 mg intravenously on day 1 of each 21-day cycle.

Study Details

The goal of this clinical trial is to learn if oral paclitaxel solution (metronomic scheduling) works to treat advanced HER2-negative breast cancer in adults. It will also learn about the safety of oral paclitaxel solution alone and combined with toripalimab. The main questions it aims to answer are: What is the optimal tolerated dose (OTD) of metronomic oral paclitaxel solution? Does metronomic oral paclitaxel plus toripalimab improve progression-free survival (PFS)? What medical problems do participants have when taking the study treatments? Researchers will evaluate metronomic oral paclitaxel alone (dose-finding) and metronomic oral paclitaxel plus toripalimab (expansion cohort) to see if the regimens work to treat advanced HER2-negative breast cancer. Participants will: Receive metronomic oral paclitaxel solution (one of two dose levels) once daily or three times weekly After OTD is determined, receive metronomic oral paclitaxel plus toripalimab every 3 weeks Visit the clinic regularly for safety checks, blood tests, and tumor imaging Keep records of treatment compliance and health-related quality of life

Key Dates

First listed
May 22, 2026
Start date
May 30, 2026
Status verified
May 2026
Primary completion
May 7, 2029
Completion
May 7, 2029

Study Design

Enrollment
44 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 TIW
  • Experimental: Metronomic Oral Paclitaxel + Toripalimab

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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