Clinical trial · Interventional
Study of Stereotactic Radiotherapy for Breast Cancer
A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
NCT03043794CI-TRIAL-00080880terminatedPhase 2Results postedClinicalTrials.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): PI closed. Unable to enroll enough patients to collect and analyze data.
Summary
Brief summary (as posted)
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
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 |
|---|---|---|---|
| Stereotactic Body Radiation Therapy SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT to the breast then surgery
- description
- Stereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy SBRT
Primary outcomes (1)
- measure
- Treatment Response Measured by Residual Cancer Burden (RCB)
- timeFrame
- 4-6 weeks
- description
- Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.
Secondary outcomes (5)
- measure
- Number of Participants With Treatment-related Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Age \> or = to 50 years of age * Invasive ductal carcinoma * Clinically and radiographically T1 tumor * Clinically node negative * Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) * Planning breast conserving surgery including sentinel node biopsy * ≥10% expression of ER and/or PR * HER2- using the current College of American Pathologists guidelines * Post-menopausal * Willing and able to provide informed consent Exclusion Criteria: * Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma * Pure DCIS without invasive cancer * Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents * Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment * Positive pregnancy test * Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. * Unable to meet dosimetric constraints due to tumor location and/or patient anatomy * Planning mastectomy * Unable to tolerate prone positioning
References
Publications (0)
Data not yet available
No reference posted for this study.