RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. - willing to sign a consent form 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. Who Should NOT Join This Trial: - 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%. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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%.

Treatments Being Tested

DRUG

dose-dense nab-paclitaxel followed by EC

Locations (1)

Shantou Central Hospital

Shantou, Guangdong, China