Clinical trial · Interventional
Hypofractionated Radiotherapy After Breast Reconstruction for Breast Cancer
Comparison of Efficacy and Safety Between Hypofractionated and Conventional Fractionated Radiotherapy After Breast Reconstruction in Breast Cancer Patients: A Phase III Randomized Controlled Clinical 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 study aims to evaluate the efficacy and safety of hyperfractionated radiotherapy (40Gy/15 fractions) compared to conventional fractionated radiotherapy (50Gy/25 fractions) in breast cancer patients undergoing breast reconstruction through a three-phase randomized controlled non-inferiority clinical trial. The primary objective is to verify that hyperfractionated radiotherapy is non-inferior to conventional fractionated radiotherapy in terms of local area control; the secondary objectives are to compare the main complications of wounds, acute and chronic toxic reactions, breast cosmetic effects, and quality of life between the two groups, thereby providing high-level evidence-based medical evidence for optimizing postoperative radiotherapy regimens for breast cancer and promoting individualized treatment. Additionally, the molecular characteristics of blood samples will be studied to identify biomarkers related to the radiotherapy process and treatment response, providing high-level evidence for immediate medium-dose low-fractionation radiotherapy after different reconstructions.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional fractionated radiotherapy | Radiation | — | UNRESOLVED |
| Whole-dose radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Whole-dose radiotherapy
- description
- The radiotherapy plan for the large-dose fractionation group: 45 Gy / 15 fractions / 3 weeks
- interventionNames
- Radiation: Whole-dose radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional fractionated radiotherapy
- description
- Conventional fractionated radiotherapy plan: 50 Gy / 25 fractions / 5 weeks
- interventionNames
- Radiation: Conventional fractionated radiotherapy
Primary outcomes (2)
- measure
- Local Control Rate
- timeFrame
- 5year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, aged 18 - 75 years 2. Karnofsky score ≥ 60 3. Invasive breast adenocarcinoma confirmed by histopathology 4. Total mastectomy (with or without preservation of nipple-areola complex) + axillary lymph node dissection/ sentinel lymph node biopsy + R0 implantation/expansion placement (negative margins) pT3 or N2-3 stage or pT1-2N1 disease 5. No distant metastasis 6. Completed standard neoadjuvant/adjunctive chemotherapy cycles 7. Signed informed consent form Exclusion Criteria: 1. If a patient has bilateral breast cancer, they will be excluded; those with distant metastasis or metastasis in the supraclavicular or internal mammary lymph nodes; those who have received radiotherapy in the past; those who have had or are currently suffering from malignant tumors, except for non-pigmented skin cancer; those who are pregnant; those with active collagen vascular diseases or other serious diseases, such as alcohol and drug abuse or mental disorders. 2. Patients with severe dysfunction of the heart, liver, or kidneys. 3. Patients with a history of radiotherapy or those who are contraindicated to radiotherapy. 4. Pregnant or lactating women. 5. Patients with severe mental or psychological disorders who cannot fulfill the requirements of the study. 6. Other patients with serious diseases that cannot meet the requirements of the study.
References
Publications (0)
Data not yet available