Clinical trial · Interventional
SOLIS: Single-Dose Radiotherapy With Omission of Lumpectomy for Intact Small Breast Cancers
Single-Dose Stereotactic Radiosurgery (SDRT) as Definitive Non-Operative Treatment for Early-Stage Breast Cancer: A Prospective Single-Arm Pilot Trial With Bayesian Safety Monitoring (SOLIS / Protocol RAD 2024)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
SOLIS is a prospective, single-arm, single-institution pilot trial evaluating single-fraction stereotactic radiotherapy (24 Gy to the planning target volume with a simultaneous integrated boost of 30 Gy to the clinical target volume) delivered with a cleared linear accelerator as definitive non-operative local treatment for early-stage, hormone receptor-positive, HER2-negative breast cancer with planned omission of lumpectomy. Adjuvant endocrine therapy is prescribed on-label. The primary endpoint is the incidence of CTCAE v5.0 Grade ≥2 skin adverse events within 90 days of treatment, monitored with a pre-specified Bayesian safety stopping rule. Secondary endpoints include biopsy-confirmed absence of residual invasive carcinoma at 12 months, imaging response on multiparametric MRI and FDG PET/CT, late toxicity, cosmesis, patient-reported outcomes, salvage surgery, and disease control through 36 months.
Conditions
Conditions (4)
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 |
| Early-Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| HER2-Negative Breast Cancer | — | UNRESOLVED | — |
| Hormone Receptor-Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocrine Therapy | Drug | Hormone Therapy | ALIAS |
| Stereotactic Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-fraction SDRT plus adjuvant endocrine therapy
- description
- Single-fraction SDRT plus adjuvant endocrine therapy.
- interventionNames
- Radiation: Stereotactic Radiation Therapy
- Drug: Endocrine Therapy
Primary outcomes (1)
- measure
- Incidence of CTCAE v5.0 Grade ≥2 skin adverse events
- timeFrame
- 90 days after SDRT
- description
- Proportion of treated patients with at least one Grade ≥2 skin AE within 90 days, graded per protocol by study research nurse practitioner.
Secondary outcomes (7)
- measure
- Absence of residual invasive carcinoma on protocol-mandated tissue sampling
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Invasive ductal carcinoma or favorable special histology confirmed by core biopsy. * Unifocal tumor ≤2 cm; estrogen receptor-positive and HER2-negative; grade 1-2; clinically node-negative (cN0). * Age ≥65, or age 50-64 when surgery is unsuitable or declined (capped at 10 of 30 participants). * Tumor ≥5 mm from skin and pectoralis; willing to receive adjuvant endocrine therapy. * Zubrod performance status 0-2; able to undergo MRI and FDG PET/CT; informed consent. Exclusion Criteria: * Multifocal or multicentric disease; pure DCIS; invasive lobular carcinoma \>10%; extensive intraductal component or diffuse calcifications. * Grade 3, triple-negative, or HER2-positive disease; nodal or distant metastases. * Prior ipsilateral breast radiation or excisional biopsy/lumpectomy; neoadjuvant chemotherapy. * Tumor \<5 mm from skin or pectoralis; inability to meet dose constraints or PTV \>60 cm³. * Connective tissue disease; prohibited other malignancy; pregnancy or lactation. * Pathogenic BRCA1, BRCA2, PALB2, or TP53 variant; investigator judgment that participation is inappropriate.
References
Publications (0)
Data not yet available