Clinical trial · Interventional
Single Dose Partial Breast Radiotherapy
Single Dose Partial Breast Radiotherapy Using Extra-cranial Radiosurgery in Patients With Early Stage Breast Cancer - a Phase I Dose Escalation Study
NCT00944528CI-TRIAL-00070879RSUcompletedPhase 1Results postedClinicalTrials.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)
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (+/- 1 week) of completing radiation.
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 |
|---|---|---|---|
| Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Single dose radiosurgery: Dose Level 1
- description
- A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
- interventionNames
- Radiation: Radiosurgery
- type
- EXPERIMENTAL
- label
- Single dose radiosurgery: Dose Level 2
- description
- A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.
- interventionNames
- Radiation: Radiosurgery
- type
- EXPERIMENTAL
- label
- Single dose radiosurgery: Dose Level 3
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast * Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery) * Clinical T1N0M0 * 55 years of age or older * Estrogen receptor (ER) positive, * No evidence of lymphovascular space invasion on initial biopsy * Not pregnant. If not post-menopausal must adhere to birth control measures * White blood cell count \> 3000, Hemoglobin \> 9, platelets \>100000 * Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min Exclusion Criteria: * Neoadjuvant chemotherapy * Breast implants * Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma) * Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length * HER-2/neu positive * Positive serum pregnancy test
References
Publications (4)
- BACKGROUNDNattinger AB, Hoffmann RG, Kneusel RT, Schapira MM. Relation between appropriateness of primary therapy for early-stage breast carcinoma and increased use of breast-conserving surgery. Lancet. 2000 Sep 30;356(9236):1148-53. doi: 10.1016/S0140-6736(00)02757-4. PMID 11030294
- BACKGROUNDHepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22. PMID 19395195
- BACKGROUNDLuini A, Orecchia R, Gatti G, Intra M, Ciocca M, Galimberti V, Veronesi P, Santos GR, Gilardi D, Veronesi U. The pilot trial on intraoperative radiotherapy with electrons (ELIOT): update on the results. Breast Cancer Res Treat. 2005 Sep;93(1):55-9. doi: 10.1007/s10549-005-3782-1. PMID 16184459
- DERIVEDHorton JK, Siamakpour-Reihani S, Lee CT, Zhou Y, Chen W, Geradts J, Fels DR, Hoang P, Ashcraft KA, Groth J, Kung HN, Dewhirst MW, Chi JT. FAS Death Receptor: A Breast Cancer Subtype-Specific Radiation Response Biomarker and Potential Therapeutic Target. Radiat Res. 2015 Nov;184(5):456-69. doi: 10.1667/RR14089.1. Epub 2015 Oct 21. PMID 26488758