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

NCT ID: NCT05728268

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dose-dense arm

Group Type: EXPERIMENTAL

dose-dense nab-paclitaxel followed by EC

Intervention Type: DRUG

dose-dense nab-paclitaxel followed by EC

Interventions

dose-dense nab-paclitaxel followed by EC

dose-dense nab-paclitaxel followed by EC

Intervention Type: DRUG

Eligibility 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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shantou University Medical College

OTHER

Sponsor Role: collaborator

Jieyang People's Hospital

OTHER

Sponsor Role: collaborator

Shantou Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Wu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shantou Central Hospital

Shantou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Haitong Lyu

Role: primary

heton25@foxmali.com

+8613631403739

Other Identifiers

ShantouCH02

Identifier Type: -

Identifier Source: org_study_id