OncoMatch/Clinical Trials/NCT05728268
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Is NCT05728268 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies dose-dense nab-paclitaxel followed by EC for breast cancer.
Treatment: dose-dense nab-paclitaxel followed by EC — Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (positive)
Estrogen receptor (ER)-positive
Required: PR (PGR) overexpression (positive)
Progesterone Receptor (PR)-positive
Required: HER2 (ERBB2) wild-type (negative)
HER2/neu-negative
Required: MKI67 overexpression (Ki67≥30%)
Ki67≥30%
Disease stage
Required: Stage IIB, IIIA, IIIB, IIIC
Excluded: Stage IV
Clinical stage IIB-IIIC. Metastatic disease [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Granulocyte count < 1.5*10^9/L, Platelet count < 100*10^9/L, Hemoglobin < 90g/L [excluded]
Kidney function
Serum Creatinine more than 1.5 upper limit [excluded]
Liver function
AST and ALT more than 2.5 upper limit [excluded]
Cardiac function
LVEF< 50% [excluded]
Granulocyte count < 1.5*10^9/L. Platelet count < 100*10^9/L. Hemoglobin < 90g/L. Serum Creatinine more than 1.5 upper limit. AST and ALT more than 2.5 upper limit. LVEF< 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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