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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShantou Central Hospital

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Metastatic disease

Pregnancy.

Nursing mothers.

Active or uncontrolled infection.

Trial design

Treatments tested in this trial

  • dose-dense nab-paclitaxel followed by EC

Treatment groups

64 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shantou Central Hospital

Lead sponsor

Shantou University Medical College

Collaborator

Jieyang People's Hospital

Collaborator