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Trial Title:
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
NCT ID:
NCT05728268
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
dose-dense nab-paclitaxel followed by EC
Description:
dose-dense nab-paclitaxel followed by EC
Arm group label:
dose-dense arm
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.
Criteria for 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%.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shantou Central Hospital
Address:
City:
Shantou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitong Lyu
Phone:
+8613631403739
Email:
heton25@foxmali.com
Start date:
August 1, 2021
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Shantou Central Hospital
Agency class:
Other
Source:
Shantou Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05728268
