OncoMatch/Clinical Trials/NCT05420454
A Study for the Neoadjuvant Treatment of Breast Cancer
Is NCT05420454 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments for breast cancer.
Treatment: Docetaxel · Carboplatin · Trastuzumab · Pertuzumab · Nab paclitaxel · Epirubicin · Cyclophosphamide · Docetaxel · Epirubicin · Cyclophosphamide · Nab paclitaxel — Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression >1% (>1%)
ER/PR positive defined as stained cells >1%
Required: PR (PGR) expression >1% (>1%)
ER/PR positive defined as stained cells >1%
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with a positive FISH test)
HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test
Required: ESR1 negative (negative)
Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative
Required: PR (PGR) negative (negative)
Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative
Required: HER2 (ERBB2) negative (negative)
Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative
Required: MKI67 expression level known (known)
known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]) and HER2 status with known Ki67 expression levels
Disease stage
Excluded: Stage DISTANT METASTASIS
The tumor is >2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Radiotherapy...for currently diagnosed breast cancer prior to study entry
Cannot have received: chemotherapy
chemotherapy...for currently diagnosed breast cancer prior to study entry
Cannot have received: biotherapy
biotherapy...for currently diagnosed breast cancer prior to study entry
Cannot have received: endocrine therapy
endocrine therapy for currently diagnosed breast cancer prior to study entry
Lab requirements
Blood counts
neutrophils≥1.5×10^9/L, platelets≥100×10^9/L, hemoglobin≥90g/L
Kidney function
serum creatinine ≤1.5 times the upper limit of normal
Liver function
AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome
Cardiac function
ECG and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%
Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%; serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome; neutrophils≥1.5×10^9/L, platelets≥100×10^9/L, hemoglobin≥90g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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