NCT06615466 Super-Hypofractionated Partial Breast Irradiation
| NCT ID | NCT06615466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-04-22 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-04-22 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 irradiation regimen is safe and effective. This study plans to continue to select low-risk breast-conserving patients, use extracorporeal intensity-modulated radiotherapy technology, refer to the radiotherapy dose fractionation model of the FAST-Forward study, and give partial breast irradiation 5.2 Gy/f/d, a total of 5 times, with a total dose of 26Gy, to further shorten the time The radiotherapy time is 1 week, and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed. Provide evidence for conducting a national multi-center phase III clinical randomized study.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06615466 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 74 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06615466 currently recruiting?
Yes, NCT06615466 is actively recruiting participants. Contact the research team at sungy@cicams.ac.cn for enrollment information.
Where is the NCT06615466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06615466 clinical trial?
NCT06615466 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 50 participants.
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