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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT03381092
Eligibility Criteria:
Inclusion Criteria:
* Invasive breast cancer diagnosed with core needle needle biopsy;
* Staging cT1b-2N0M0;
* ER/PR positive cells ratio \<10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
* Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
* With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
* Voluntarily join the study and sign an informed consent form.
Exclusion Criteria:
* History of malignant tumors.
* With chemotherapy contraindications.
* Recieved any form of surgery of primary tumor or axillary lymph nodes.
* Refuse neoadjuvant chemotherapy.
* Refuse assessment examinations.
* Refuse to join the study.
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
70 Years
Study:
NCT03381092
Study Brief:
Protocol Section:
NCT03381092