Partial breast irradiation for early-stage breast cancer
Official title: Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT06615466 · Data updated 2026-11-12
This study is testing if a shorter 2-week radiation treatment for early-stage breast cancer is just as safe and effective as the standard 3-week treatment for women who have had breast-conserving surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 74 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 22, 2022 |
| Main results expected | December 2024 |
| Study ends | September 2027 |
| Registry record updated | September 26, 2024 |
| Trial ID | NCT06615466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 45 to 75 years with early-stage low-risk breast cancer who have undergone breast-conserving surgery.
✕Probably not a fit
Patients with multiple primary tumors, high-grade invasive ductal carcinoma, or certain other specific breast cancer types may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and efficacy of a 2-week schedule of partial breast irradiation compared to a 3-week whole-breast radiotherapy regimen for women with early-stage low-risk breast cancer following breast-conserving surgery. It aims to identify the appropriate patient population and optimal dose fractionation model for partial breast irradiation in the Chinese demographic. The study will enroll women aged 45 to 75 years with specific tumor characteristics and will assess outcomes within a defined timeframe post-surgery.
Why it matters
Potential benefit: If successful, this approach could provide a more efficient and effective radiotherapy option for patients with early-stage breast cancer, potentially reducing treatment time and side effects.
How similar studies have gone: Other studies have shown promising results with partial breast irradiation, but this specific approach in the Chinese population is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Guangyi Sun
- Email: sungy@cicams.ac.cn
- Phone: 086-18811100731
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Identifying genetic markers for radiation therapy response in breast cancer
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Radiotherapy options for low-risk breast cancer patients
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Comparing axillary radiotherapy and lymphadenectomy in breast cancer patients after neoadjuvant therapy
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Comparing 1-week versus 2-week radiotherapy for high-risk breast cancer patients
This study is testing whether a shorter 1-week radiotherapy treatment is just as effective as a 2-week treatment for patients with high-risk breast cancer after surgery.
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Gyrotonic exercise for elders with breast cancer and Behcet disease
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.