Clinical trial · Interventional
MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer
NCT03863301CI-TRIAL-00050342ABLATIVE-2withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no participants enrolled
Summary
Brief summary (as posted)
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided single dose preoperative PBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MR-guided single dose preoperative PBI
- interventionNames
- Radiation: MR-guided single dose preoperative PBI
Primary outcomes (1)
- measure
- Pathologic complete response (pCR)
- timeFrame
- up to 12 months
- description
- pCR is assessed 6 or 12 months following single dose radiotherapy. Patients will undergo breast-conserving surgery.
Secondary outcomes (15)
- measure
- Radiologic response on MRI
- timeFrame
- up to 12 months
- description
- A 3T MRI will be made 1 week, 3 months, 6 months, 9 months and 12 months following radiotherapy. This will be correlated to the pathologic response.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * WHO performance scale ≤2. * Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI. * Patients with an indication for chemotherapy or immunotherapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible. * Tumor size as assessed on MRI. * On tumor biopsy: * Bloom-Richardson grade 1 or 2. * Non-lobular invasive histological type carcinoma. * LCIS or (non-extensive) DCIS is accepted. * ER positive tumor receptor. * HER2 negative tumor. * Tumor-negative sentinel node. * Adequate communication and understanding skills of the Dutch language. Exclusion Criteria: * Legal incapacity. * BRCA1, BRCA2 or CHEK2 gene mutation. * Previous history of breast cancer or DCIS. * Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion. * Collagen synthesis disease. * Signs of extensive DCIS component on histological biopsy or imaging. * Invasive lobular carcinoma. * MRI absolute contraindications as defined by the Department of Radiology. * Nodal involvement with cytological or histological confirmation. * Indication for treatment with (neo-)adjuvant chemotherapy. * Non-feasible dosimetric RT plan.
References
Publications (0)
Data not yet available
No reference posted for this study.