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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07469267
Eligibility Criteria:
Inclusion Criteria:
1. Female ≥ 18 years of age;
2. Newly diagnosed primary invasive breast cancer;
3. Clinically stage T1-3N0M0;
4. Patients received surgery as first treatment,and have undergone breast conserving-surgery or mastectomy (with or without breast reconstruction) with negative margins;
5. Have one or two macrometastases (\>2 mm) at sentinel lymph node biopsy,and without further axillary lymph node dissection;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
7. Will receive endocrine therapy for at least 5 years for estrogen receptor (ER) and/or progesterone receptor (PR) positive patients; will receive anti-HER2 (human epidermal growth factor receptor 2) therapy for 1 year for HER2 positive patients;
8. Radiation therapy must begin no later than 12 weeks after the last dose of adjuvant chemotherapy or the last breast cancer surgery if no adjuvant chemotherapy;
9. Patients have adequate organ function;
10. Acquirement of informed consent.
Exclusion Criteria:
1. Patients have received neoadjuvant systemic therapy;
2. Clinical stage T4 or IV (metastatic) breast cancer, or presence of regional metastases before surgery;
3. History of any prior ipsilateral or contralateral invasive breast cancer, history of other malignancies except for appropriately treated skin basal cell carcinoma and cervical carcinoma in situ;
4. History of previous radiotherapy towards the ipsilateral chest/lymph nodes.
5. The ipsilateral axillary lymph node dissection or other previous axillary surgery;
6. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, or psychiatric disease), inability to tolerate radiotherapy or systemic therapy if indicated;
7. Current pregnancy and/or lactation;
8. Inability or unwillingness to comply with protocol requirements.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07469267
Study Brief:
Protocol Section:
NCT07469267