Clinical trial · Interventional
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare. Some studies have shown that NART followed immediate implant-based breast reconstruction seems feasible and can be safely attempted. It's well known that radiotherapy after implant-based breast reconstruction have negative effects on implant and cosmetic results. So, investigators conducted a polit study to learn about acute post-surgical complications following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Implant Breast Reconstruction | — | UNRESOLVED | — |
| Neoadjuvant Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant radiotherapy group
- description
- Radiotherapy followed by skin-sparing mastectomy and immediate implant-based reconstruction in HBCH
- interventionNames
- Radiation: Neoadjuvant radiotherapy
Primary outcomes (1)
- measure
- Postoperative complications at 3 months following skin-sparing mastectomy and immediate implant-based breast reconstruction after NART
- timeFrame
- 3 months following skin-sparing mastectomy and immediate breast reconstruction
- description
- Surgical complications are defined as any complication requiring surgical intervention necessary within a period up to three months after the final reconstruction. Including Infection, hematoma , loss of implant or flap, fat necrosis, wound breakdown,defined and scored using the C-DC37.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available