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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT04875351
Eligibility Criteria:
Inclusion Criteria:
* Early stage (I, II or III) female breast cancer patients, who have completed 4-7 years of primary adjuvant endocrine therapy
* Patient was diagnosed with invasive breast carcinoma (ductal, lobular, or mixed ductal/lobular).
* The primary tumor was hormone receptor positive (HR+), i.e. estrogen receptor-positive and/or progesterone receptor-positive.
* The primary tumor was HER2 negative or positive and node-negative or node-positive with 1-3 positive lymph nodes.
* Subject has pre-treatment breast tumor tissue \[formalin fixed and paraffin embedded (FFPE)\] from a previous breast-conserving surgery, mastectomy or core needle biopsy available for testing by the Sponsor.
Exclusion Criteria:
* Patient has distant metastatic disease (M1).
* Patient was diagnosed with metaplastic breast cancer, carcinosarcoma, sarcoma, neuroendocrine carcinoma, adenoid cystic carcinoma, or phyllodes tumor.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04875351
Study Brief:
Protocol Section:
NCT04875351