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

NCT05728268 | Recruiting Phase 2 DMC

• 1 other identifier: ShantouCH02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• RCB

  Residual Cancer Burden

  7 days

Study Arms (1)

dose-dense arm

EXPERIMENTAL

Drug: dose-dense nab-paclitaxel followed by EC

Interventions

dose-dense nab-paclitaxel followed by EC DRUG

dose-dense nab-paclitaxel followed by EC

dose-dense arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Shantou Central Hospital: lead
• Shantou University Medical College: collaborator
• Jieyang People's Hospital: collaborator

Study Sites (1)

Shantou Central Hospital

Shantou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: August 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)