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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • dose-dense nab-paclitaxel followed by EC

    Drug

    dose-dense nab-paclitaxel followed by EC

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: dose-dense armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RCB

Residual Cancer Burden

Time frame
7 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shantou Central Hospital

Lead sponsor

Shantou University Medical College

Collaborator

Jieyang People's Hospital

Collaborator