Comparing hypofractionated and conventional radiation for breast cancer patients with implants
Official title: Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
Run by The First Affiliated Hospital with Nanjing Medical University · NCT06830083 · Data updated 2026-11-12
This study is testing whether a shorter, more intense radiation treatment is safer and more effective than standard radiation for women with breast implants after mastectomy for breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 840 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | December 30, 2030 |
| Study ends | December 2033 |
| Registry record updated | February 17, 2025 |
| Trial ID | NCT06830083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women over 18 years old with stage I-III breast cancer who have undergone complete breast cancer resection and immediate reconstructive surgery.
✕Probably not a fit
Patients who have undergone auto-reconstruction surgery or have clinical or pathological T4 breast cancer will 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 trial evaluates the safety and efficacy of hypofractionated radiation therapy compared to conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction for breast cancer. The study aims to assess reconstruction complications, side effects of radiotherapy, and both cosmetic and oncologic outcomes. It is a randomized trial that builds on previous research, including the FABREC trial, which explored the impact of different radiation fractionation methods on patient well-being. The findings will help determine the optimal approach for integrating radiation therapy with implant-based breast reconstruction.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that minimize complications and enhance quality of life for breast cancer patients undergoing reconstruction.
How similar studies have gone: Previous studies, including the FABREC trial, have explored similar approaches, but this trial aims to provide further insights into the optimal radiation techniques for patients with implant-based reconstruction.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Pathological diagnosis of stage I-III breast cancer (non-T4), \>18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant) Exclusion Criteria: 1. Auto-reconstruction surgery 2. Clinical or pathological T4 3. Both sides need radiotherapy 4. Have a history of chest radiotherapy 5. Pregnancy/lactation 6. Participate in other drug clinical trials
Where it's running
-
Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Jiangsu Province People's Hospital
- Email: 13770662828@163.com
- Phone: 86-025-68307676
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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.