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Super-Hypofractionated Partial Breast Irradiation

RecruitingNAAges 45 Years - 74 YearsFemaleCancer Institute and Hospital, Chinese Academy of…
NCT06615466 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Partial breast irradiation is currently a hot topic in clinical research, but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive. Foreign studies have mostly selected patients with low risk of recurrence. Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China. It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model. A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation (40Gy/10f) and a 3-week schedule of whole-breast radiotherapy (43.5Gy/15f) in patients with early-stage low-risk breast cancer after breast-conserving surgery. , preliminary results show that the 2-week partial breast

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📋 Eligibility rules (as published)
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
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What it tests

  • Partial Breast Irradiation
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Where

1 site
Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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