Clinical trial · Interventional
PBI for Low-risk Breast Cancer
A Randomized Phase III Trial Comparing 1-Week vs. 3-Week Partial Breast Irradiation Via IMRT After Breast-Conserving Surgery for Clinical Low-Risk Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Why stopped (as posted): funding issue
Summary
Brief summary (as posted)
This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.
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 |
|---|---|---|---|
| Early-Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1-week PBI | Radiation | — | UNRESOLVED |
| 3-week PBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 3-week partial breast irradiation (PBI）
- description
- Control group
- interventionNames
- Radiation: 3-week PBI
- type
- EXPERIMENTAL
- label
- 1-week PBI
- description
- Experimental group
- interventionNames
- Radiation: 1-week PBI
Primary outcomes (1)
- measure
- 3-year adverse cosmesis
- timeFrame
- 3 years
- description
- Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients with an estimated life expectancy greater than 5 years. * Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS). * For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm. * For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm. * Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation. * ECOG performance status 0 or 1. * Eligible for systemic therapy, without prior neoadjuvant systemic therapy. * Able to tolerate radiotherapy procedures and position immobilization. * No contraindications to radiotherapy. * Written informed consent provided. Exclusion Criteria: * Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma). * Positive axillary, internal mammary, or supraclavicular lymph nodes. * Presence of distant metastasis. * Paget's disease of the nipple. * History of prior ipsilateral or contralateral invasive breast cancer or DCIS. * Bilateral breast cancer. * Known germline BRCA1 or BRCA2 mutation. * Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes. * Active or prior second malignancy (except adequately treated non-melanoma skin cancer). * Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy. * Pregnant or lactating patients. * Inability or unwillingness to comply with scheduled follow-up visits. Inability or unwillingness to provide written informed consent.
References
Publications (0)
Data not yet available