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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT06686459
Eligibility Criteria:
Inclusion Criteria:
* 1\. Female patients aged 18-70 years. 2. ECOG performance status of 0-2. 3. Newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypN+) and negative surgical margins.
4\. No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER/PR-positive patients, willing to receive anticipated 5 years of endocrine therapy.
7\. For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy.
8\. For patients requiring neoadjuvant/adjuvant chemotherapy, must have completed chemotherapy.
9\. Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%.
10\. Must undergo adjuvant IMRT (Intensity-Modulated Radiation Therapy). 11. Capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete All-In-One radiotherapy.
12\. Have follow-up conditions and are willing to adhere to follow-up. 13. Signed an informed consent form.
Exclusion Criteria:
* 1\. Synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection.
2\. Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall.
3\. The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina.
5\. History of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, and carcinoma in situ of the cervix).
6\. All-in-one one-stop radiotherapy has not been completed.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06686459
Study Brief:
Protocol Section:
NCT06686459