OncoMatch/Clinical Trials/NCT07739485
Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
Is NCT07739485 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Epirubicin and cyclophosphamide followed by paclitaxel oral solution for triple -negative breast cancer.
Treatment: Epirubicin and cyclophosphamide followed by paclitaxel oral solution — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (absent (<1%))
ER <1%
Required: PR (PGR) expression (absent (<1%))
PR <1%
Required: HER2 (ERBB2) wild-type (negative (IHC 0, IHC 1+, or IHC 2+ with FISH-negative))
HER2-negative [IHC 0, IHC 1+, or IHC 2+ with FISH-negative]
Disease stage
Excluded: Stage T1CN0M0
clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded)
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demographics
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L
Kidney function
BUN and creatinine ≤ 1.5 × ULN; creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
Liver function
total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following: Hematology: ANC ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L. Blood chemistry: total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 1.5 × ULN; BUN and creatinine ≤ 1.5 × ULN; creatinine clearance ≥ 50 mL/min by the Cockcroft-Gault formula. Left ventricular ejection fraction (LVEF) ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07739485 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify