Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGdose-dense nab-paclitaxel followed by EC
dose-dense nab-paclitaxel followed by EC
Sponsors
Shantou University Medical College
Jieyang People's Hospital
Shantou Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RCB | 7 days | Residual Cancer Burden |
Countries
China
Outcome results
None listed