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

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shantou Central Hospital
• Treatments: Paclitaxel

Criteria

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%.