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

December 28, 2025 updated by: Zhiyong Wu, Shantou Central Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shantou, Guangdong, China, 510000
        • Recruiting
        • Shantou Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dose-dense arm
Drug: dose-dense nab-paclitaxel followed by EC
dose-dense nab-paclitaxel followed by EC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RCB
Time Frame: 7 days
Residual Cancer Burden
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shantou Central Hospital

Collaborators

Jieyang People's Hospital
Shantou University Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

February 4, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShantouCH02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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