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RecruitingNCT05728268Updated Jan 2, 2026

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

A Phase 2 interventional study of dose-dense nab-paclitaxel followed by EC in Breast Cancer, sponsored by Shantou Central Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Shantou Central Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Aug 2021, registered Feb 2023).
  • Started Aug 2021; still recruiting 5 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 64 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shantou Central Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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%.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    dose-dense arm

    Drug: dose-dense nab-paclitaxel followed by EC

Interventions

  • Drugdose-dense nab-paclitaxel followed by EC

    dose-dense nab-paclitaxel followed by EC

06

What researchers measure

Primary outcomes

  1. RCB

    Residual Cancer Burden

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • Shantou Central Hospital
    Shantou, Guangdong 510000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05728268
Lead sponsor
Shantou Central Hospital
Collaborators
Shantou University Medical College, Jieyang People's Hospital
Responsible party
Zhiyong Wu (Dr., Shantou Central Hospital) — Principal investigator
First posted
Feb 15, 2023
Start date
Aug 1, 2021
Primary completion
Dec 30, 2024
Completion
Dec 30, 2025 (estimated)
Last update
Jan 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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