Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Recruiting · NCT05728268 · Interventional (participants receive a specific treatment) · Lead sponsor: Shantou Central Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Shantou Central Hospital - Shantou, Guangdong, China