OncoMatch/Clinical Trials/NCT07739511
Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
Is NCT07739511 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies Paclitaxel oral solution plus Trastuzumab and Pertuzumab for her2 + breast cancer.
Treatment: Paclitaxel oral solution plus Trastuzumab and Pertuzumab — This is a multicenter, open-label, dose-finding 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 combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and 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
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ with fish amplification)
Disease stage
Excluded: Stage T1CN0M0
Performance status
ECOG 0–1(Restricted strenuous activity)
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 (Cr) ≤ 1.5 × ULN; creatinine clearance (CrCl) ≥ 50 mL/min by Cockcroft-Gault formula
Liver function
total bilirubin (TBIL) ≤ 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: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 1.5 × ULN; BUN and Cr ≤ 1.5 × ULN; CrCl ≥ 50 mL/min by 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 NCT07739511 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 ERBB2?
Yes, ERBB2 overexpression 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 qualifyRelated pages