Super-Hypofractionated Partial Breast Irradiation

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating early-stage breast cancer called super-hypofractionated partial breast irradiation. The goal is to deliver targeted radiation therapy to the part of the breast where the cancer was removed, but in a shorter time frame of just one week, compared to longer traditional schedules. This study aims to find out if this quicker method is safe and effective for women who have low-risk breast cancer after breast-conserving surgery.

To be eligible for this trial, participants need to be women aged between 45 and 75 years who have a specific type of early-stage breast cancer that meets certain criteria. They should have a life expectancy of more than five years and must start treatment within a few weeks after their surgery. Participants will receive radiation therapy five times over the week, and the study will monitor any side effects and how well the treatment controls the cancer. This research is important because it could help establish a faster, effective treatment option for patients in China and support further studies across multiple centers.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥45 years old, \<75 years old women
• • 2. Life expectancy \>5 years
• • 3. Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)
• • 4. Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor
• • ≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)
• • 5. Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
• • 6. Single focus (with MRI diagnosis)
• • 7. Vascular tumor thrombus negative
• • 8. ER and/or PR positivity (defined as strong positivity in \>1% of tumor cell nuclei)
• • 9. Negative pathological margin≥2mm
• • 10. Place metal markers on the tumor bed
• • 11. Sign the informed consent form
• Exclusion Criteria:
• • 1. Multiple primary tumors
• • 2. Invasive ductal carcinoma grade 3
• • 3. Invasive micropapillary carcinoma
• • 4. Lobular carcinoma in situ
• • 5. Invasive lobular carcinoma
• • 6. Simple nipple paget's disease
• • 7. Oncoplastic surgery
• • 8. Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
• • 9. Previous or simultaneous contralateral breast cancer
• • 10. History of ipsilateral chest wall radiotherapy
• • 11. Have active collagen vascular disease