Actively Recruiting
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Led by Shantou Central Hospital · Updated on 2026-01-02
64
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
S
Shantou Central Hospital
Lead Sponsor
S
Shantou University Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years old
- Newly diagnosed breast cancer patients
- Planned to receive neoadjuvant chemotherapy
- Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone receptor (PR)-positive
- HER2/neu-negative
- Ki67 proliferation index of 30% or higher
- Clinical stage IIB to IIIC breast cancer
- Signed and understood informed consent form
- Agrees to attend all follow-up visits
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Women of childbearing potential must have a negative serum pregnancy test
You will not qualify if you...
- Metastatic disease
- Pregnancy
- Nursing mothers
- Active or uncontrolled infection
- Presence of other malignancies
- Granulocyte count less than 1.5 x 10^9/L
- Platelet count less than 100 x 10^9/L
- Hemoglobin less than 90 g/L
- Serum creatinine more than 1.5 times upper limit
- AST and ALT more than 2.5 times upper limit
- Left ventricular ejection fraction (LVEF) less than 50%
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shantou Central Hospital
Shantou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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