Neoadjuvant radiotherapy followed by immediate breast reconstruction
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
NA · Hubei Cancer Hospital · NCT05992870
This study is testing if giving radiation therapy before breast surgery and immediate reconstruction can lead to better results and fewer problems for women with breast cancer compared to the usual approach.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Hubei Cancer Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05992870 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and safety of neoadjuvant radiotherapy (NART) followed by skin-sparing mastectomy and immediate implant-based breast reconstruction in women with breast cancer. The researchers aim to assess acute post-surgical complications and compare outcomes to traditional postmastectomy radiotherapy (PMRT), which is known to negatively impact implant and cosmetic results. By exploring this approach, the study seeks to determine if NART can lead to better cosmetic outcomes and fewer complications than PMRT, potentially shortening the time from diagnosis to treatment completion.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with confirmed breast cancer who require mastectomy and have an indication for radiotherapy.
Not a fit: Patients with a history of breast cancer, inflammatory breast cancer, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cosmetic outcomes and reduce complications for patients undergoing breast reconstruction after mastectomy.
How similar studies have performed: While some studies have shown the feasibility of NART followed by immediate DIEP flap reconstruction, this specific approach with implant-based reconstruction is less commonly explored and may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Women \>18 years with histopathologically-confirmed breast cancer, who: * require mastectomy for any reason * a known indication for (adjuvant) radiotherapy * require implant-based breast reconstruction Exclusion Criteria: * Inability to give informed consent * MDT unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings * Previous history of breast cancer or another malignancy for which radiotherapy of the breast or axilla * Pregnant or lactating * inflammatory breast cancer
Where this trial is running
Wuhan, Hubei
- Xinhong Wu — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Xinhong Wu, MD
- Email: 34053889@qq.com
- Phone: +8618602726300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy, neoadjuvant radiotherapy, implant, breast reconstruction