Clinical trial · Interventional
Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer
Single Pre-Operative Radiation Therapy - With Delayed Surgery (SPORT-DS) for Low Risk Breast Cancer: A Phase 1 Study
NCT03917498CI-TRIAL-00082701SPORT-DSactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.
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 |
|---|---|---|---|
| Single Pre-Operative Radiation Therapy - with Delayed Surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Pre-Operative Radiation Therapy with Delayed Surgery
- description
- Single Pre-Operative Radiation Therapy with Delayed Surgery
- interventionNames
- Radiation: Single Pre-Operative Radiation Therapy - with Delayed Surgery
Primary outcomes (1)
- measure
- rate of pathological complete response
- timeFrame
- at the time of surgery
Secondary outcomes (1)
- measure
- incidence of radiation toxicity
- timeFrame
- in the 2 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female aged 65 years or older 2. World Health Organization (WHO) performance status 0-2 3. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start 4. Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start 5. Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound 6. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound 7. Estrogen receptor status (ER) positive on biopsy 8. Her2 negative on biopsy 9. Grade 1 or 2 on biopsy 10. Planned surgery is a partial mastectomy with sentinel lymph node biopsy 11. Localisation markers placed before treatment Exclusion Criteria: 1. Age less than 65 years 2. A known deleterious mutation in BRCA 1 and/or BRCA 2 3. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound 4. Tumor histology limited to lobular carcinoma only 5. Clinically positive axillary nodes (cN+) 6. Lymphovascular invasion on biopsy 7. Pure ductal or lobular carcinoma in situ on biopsy 8. Extensive intraductal component on biopsy 9. Neoadjuvant hormonal manipulation or chemotherapy 10. Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial) 11. More than one primary tumor in different quadrants of the same breast 12. Diffuse microcalcifications on mammography 13. Paget's disease of the nipple 14. Previous irradiation to the ipsilateral breast 15. Presence of an ipsilateral breast implant or pacemaker 16. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment 17. Estrogen receptor status (ER) not known 18. Currently pregnant or lactating 19. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol 20. Geographic inaccessibility for follow-up 21. Lack of preoperative staging with breast and axillary ultrasound 22. Inability to adequately plan the patient for the experimental technique
References
Publications (1)
- DERIVEDLavigne D, Hijal T, Vavassis P, Guilbert MC, Sideris L, Dube P, Gervais MK, Leblanc G, Dufresne MP, Nguyen D, Tiberi D, Mahmoud D, Yassa M. Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial. Radiother Oncol. 2024 Nov;200:110515. doi: 10.1016/j.radonc.2024.110515. Epub 2024 Aug 30. PMID 39218041