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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT03460067
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent.
* Karnofsky Performance Status 50% to 100% (Appendix A).
* Women 40 years of age or older with a diagnosis of invasive ductal carcinoma
* Her-2 3+ or FISH ratio of 2.2 or higher, background gene expression with normal copy number
* Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:
* No spontaneous menses \> 1 year, or
* Bilateral surgical oophorectomy, or
* No menses for \< 1 year with FSH and estradiol levels in according to institutional standards
* cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal mammary nodes on MRI or ultrasound)
* Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
* Patients are required to undergo lumpectomy with sentinel lymph node biopsy
* Pathologic review shows no evidence of residual disease in the tumor bed (to also include no evidence of residual DCIS)
* Tumor bed should be no larger than 5 cm in size on pathologic review
* Fibrotic area of prior tumor located at least 3 mm away from surgical margins
* No evidence of treatment related change in the lymph nodes on pathologic review
Exclusion Criteria
* Diagnosis of inflammatory breast cancer
* Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)
* Diagnosis of metastatic disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT03460067
Study Brief:
Protocol Section:
NCT03460067