Clinical trial · Interventional
PRISM Trial: Partial Breast Versus Whole Breast Radiation in Early Breast Cancer
PRISM Trial: Partial Breast Versus Whole Breast Radiation in Ultra-Hypofractionated Irradiation; A Multicenter Study of Toxicity and DosiMetrics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
Breast-conserving surgery followed by radiotherapy is a standard treatment for women with early-stage breast cancer. Whole breast irradiation (WBI) is the current standard approach, but partial breast irradiation (PBI), which treats only the area surrounding the original tumor, may reduce radiation exposure to healthy tissues while maintaining similar treatment effectiveness. The PRISM Trial is a prospective, multicenter, phase II randomized controlled trial that will compare ultra-hypofractionated PBI and WBI using the same radiation schedule of 26 Gy delivered in five fractions with intensity-modulated radiotherapy (IMRT). One hundred eligible women with early-stage breast cancer will be randomly assigned to receive either PBI or WBI after breast-conserving surgery. The primary objective is to compare acute treatment-related skin toxicity between the two treatment approaches using both clinician-reported Common Terminology Criteria for Adverse Events (CTCAE v6.0) and patient-reported outcomes (PRO-CTCAE). Secondary objectives include evaluation of early and late toxicity, dosimetric parameters, normal tissue complication probability (NTCP), and the relationship between radiation dose distribution and clinical toxicity over 12 months of follow-up.
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 Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultra-Hypofractionated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
| Ultra-Hypofractionated Whole Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Partial Breast Irradiation (PBI)
- interventionNames
- Radiation: Ultra-Hypofractionated Partial Breast Irradiation
- type
- ACTIVE_COMPARATOR
- label
- Whole Breast Irradiation (WBI)
- interventionNames
- Radiation: Ultra-Hypofractionated Whole Breast Irradiation
Primary outcomes (1)
- measure
- Number of Participants With Acute Treatment-Related Adverse Events by CTCAE Grade and Acute Treatment-Related Symptoms Reported Using PRO-CTCAE
- timeFrame
- 3 months after completion of radiotherapy
- description
- Number of participants experiencing acute treatment-related adverse events, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, and number of participants reporting acute treatment-related symptoms using the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged ≥45 years. * Newly diagnosed, histologically confirmed breast carcinoma, including Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), or Ductal Carcinoma in Situ (DCIS). * Early-stage disease (T1-T2, node-negative \[N0\]), with no evidence of distant metastasis. * Hormone receptor-positive disease (ER and/or PR positive). * HER2-positive disease, provided patients have received or are receiving appropriate HER2-targeted therapy, as per institutional practice. * Patients who have undergone breast-conserving surgery with no tumor on inked margins or no residual disease following re-excision. Exclusion Criteria: * Age \<45 years. * Multicentric disease. * Locally advanced or node-positive disease (T3-T4 and/or N+) or evidence of distant metastasis. * Lobular Carcinoma In Situ (LCIS). * Triple-negative breast cancer. * Positive surgical margins or incomplete breast-conserving surgery not suitable for re-excision. * Prior ipsilateral breast irradiation. * Non-breast malignancy within the past 5 years, except treated non-melanoma skin cancer or in-situ carcinoma. * Pregnancy or lactation at enrollment. * Inability to identify the tumor bed on planning Computed Tomography (CT), such as absence of surgical clips or seroma. * Unacceptable radiotherapy planning feasibility for the experimental technique according to protocol constraints.
References
Publications (0)
Data not yet available