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NCT Number: NCT05728268

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

dose-dense nab-paclitaxel followed by EC

Drug

dose-dense nab-paclitaxel followed by EC

Primary outcomes

  1. RCB

    Time frame: 7 days

    Residual Cancer Burden

Sponsors and collaborators

Lead sponsor

Shantou Central Hospital

Other

Collaborators

  • Jieyang People's Hospital
  • Shantou University Medical College

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Feb 15, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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