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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT06733233
Eligibility Criteria:
Inclusion Criteria:
1. Adults between the ages of 18 and 70 at the time of signing the informed consent form.
2. An Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
3. Previously untreated, operable invasive breast cancer measuring greater than 2.0 centimeters (cT2) with positive clinical lymph nodes (cN1/cN2); or clinically staged T3-T4, clinically lymph node-negative (N0) or clinically lymph node-positive (cN1/cN2) without distal metastases.
4. Tumors with low levels of HER2 expression by immunohistochemistry (IHC), defined as IHC 1+ or IHC 2+ and FISH negative.
5. Tumor documented as HR-positive (ER and/or PgR-positive \[ER or PgR ≥1%\] by local assessment according to ASCO-CAP guidelines).
6. Patients who agree to undergo surgical treatment for breast cancer when they meet surgical criteria after neoadjuvant therapy.
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer and bilateral breast cancer
2. Previous history of invasive breast cancer.
3. Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
4. Other malignant tumors within 5 years, excluding cured carcinoma in situ of the cervix and non-melanoma skin cancers.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06733233
Study Brief:
Protocol Section:
NCT06733233