Neoadjuvant dose-dense chemotherapy for HR-positive/HER2-negative breast cancer with high tumor proliferation

Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index

This trial tests whether giving dose-dense nab-paclitaxel followed by epirubicin/cyclophosphamide before surgery helps women (18–70) with HR-positive, HER2-negative breast cancer and high Ki‑67 (≥30%) respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shantou Central Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shantou, Guangdong)
• Trial ID: NCT05728268 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial gives neoadjuvant dose-dense nab-paclitaxel followed by epirubicin/cyclophosphamide to women with HR-positive, HER2-negative breast cancer and a high proliferation index (Ki‑67 ≥30%). Eligible patients are clinical stage IIB–IIIC, ECOG 0–1, and planning preoperative chemotherapy. The study will monitor tumor response and safety during and after treatment. It will also explore biomarkers such as MammaPrint and BluePrint to help identify which patients gain the most benefit.

Who should consider this trial

Good fit: Women aged 18–70 with newly diagnosed, non-metastatic HR-positive, HER2-negative breast cancer (clinical stage IIB–IIIC), Ki‑67 ≥30%, ECOG 0–1, and planned neoadjuvant chemotherapy are ideal candidates.

Not a fit: Patients with HER2-positive disease, low Ki‑67, metastatic cancer, significant organ dysfunction, poor blood counts, pregnancy or breastfeeding, or LVEF <50% are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could increase tumor response before surgery and help identify which HR+/HER2- patients benefit most from dose-dense chemotherapy, potentially lowering recurrence risk.

How similar studies have performed: Previous trials have shown dose-dense chemotherapy can reduce recurrence and death overall, but results in HR+/HER2- patients have been mixed, and using Ki‑67 and genomic assays like MammaPrint/BluePrint to select patients is a relatively new strategy.

Eligibility criteria

Inclusion Criteria:

* Females with age of 18 to 70 years old.
* Newly diagnosed breast cancer patients.
* Planned neoadjuvant chemotherapy.
* Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
* HER2/neu-negative.
* Ki67≥30%.
* Clinical stage IIB-IIIC.
* Informed consent form understood and signed.
* Patient agrees to all follow-up visits.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Metastatic disease
* Pregnancy.
* Nursing mothers.
* Active or uncontrolled infection.
* Presence of another malignancies.
* 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%.

Where this trial is running

Shantou, Guangdong

• Shantou Central Hospital — Shantou, Guangdong, China (Recruiting)

Conditions Breast Cancer