Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT05728268
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%.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05728268
Study Brief:
Protocol Section:
NCT05728268