Clinical trial · Interventional
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.
Conditions
Conditions (2)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ConvRT | Radiation | — | UNRESOLVED |
| HypoRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventionally fractionated radiotherapy
- interventionNames
- Radiation: ConvRT
- type
- EXPERIMENTAL
- label
- Hypofractionated radiotherapy
- interventionNames
- Radiation: HypoRT
Primary outcomes (1)
- measure
- The rate of unplanned reoperation
- timeFrame
- 3 years
- description
- Surgery performed to treat complications related to breast reconstruction.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥ 18 years. * Pathologically confirmed unilateral primary invasive breast cancer. * Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection). * Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement. * Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols. * Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0). * Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy. * ECOG performance status 0-1. * Prior non-breast malignancy permitted if disease-free for \> 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval. * Estimated life expectancy ≥ 10 years. * Written informed consent provided. Exclusion Criteria: * Pregnant or lactating patients. * Prior history of breast cancer. * Bilateral breast cancer. * Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas. * T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy). * Non-breast malignancy within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma). * Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.
References
Publications (0)
Data not yet available