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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728268
• Other study ID #: ShantouCH02
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Shantou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• dose-dense nab-paclitaxel followed by EC
dose-dense nab-paclitaxel followed by EC

Locations

Country	Name	City	State
China	Shantou Central Hospital	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shantou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RCB	Residual Cancer Burden	7 days