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Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study

NCT07739485 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-04

No results posted yet for this study

Summary

This is a multicenter, open-label, dose-escalation trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution followed by epirubicin plus cyclophosphamide therapy. Eligible triple-negative breast cancer patients are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).

Conditions

  • Triple -Negative Breast Cancer

Interventions

DRUG

Epirubicin and cyclophosphamide followed by paclitaxel oral solution

Cycles 1-4: Epirubicin 90 mg/m² plus cyclophosphamide 600 mg/m² by intravenous infusion on day 1 (D1) of each cycle; one treatment cycle administered every 3 weeks. Cycles 5-8: Paclitaxel oral solution 125, 150, or 175 mg/m², given twice daily on days 1, 8, and 15 of each cycle; one cycle every 3 weeks.

Sponsors & Collaborators

  • Liu Shu

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-07-30
Completion
2029-07-30

Countries

  • China

Study Locations

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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 NCT07739485 on ClinicalTrials.gov