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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT05736367
Eligibility Criteria:
Inclusion Criteria:
* Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy.
* Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0)
* Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy).
* Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection.
Exclusion Criteria:
* Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.
* Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer.
* Concomitant active malignancy
* Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05736367
Study Brief:
Protocol Section:
NCT05736367