OncoMatch/Clinical Trials/NCT05728268
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Is NCT05728268 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT05728268 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 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIB or IIIA or IIIB or IIIC is required.
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