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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: dose-dense nab-paclitaxel followed by EC

• Registration Number: NCT05728268
• Lead Sponsor: Shantou Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-04
• Last Update Submitted: 2023-02-04
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Primary Completion: 2024-07-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose-dense arm	dose-dense nab-paclitaxel followed by EC	-

Primary Outcome Measures

Name	Time	Method
RCB	7 days	Residual Cancer Burden

Trial Locations

Locations (1)

Shantou Central Hospital; 🇨🇳 Shantou, Guangdong, China