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Recruiting Phase 2

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

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About this study

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.

Condition
Breast Cancer
Tested
dose-dense nab-paclitaxel followed by EC
Sponsor
Shantou Central Hospital

Who can join

Age
18 to 70 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Eligible sex: Female
  • Study condition: Breast Cancer
  • 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 11

  • 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%.

Where

1 site, 1 recruiting

Shantou Central Hospital

Shantou, Guangdong, China

Recruiting

Potential match only. Final eligibility is determined by the study team.