Clinical trial · Interventional
Node Negative, Invasive Breast Cancer Single Fraction IOERT
Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
NCT02370797CI-TRIAL-00085162active 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)
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
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 Fraction IOeRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Fraction IOeRT
- description
- A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
- interventionNames
- Radiation: Single Fraction IOeRT
Primary outcomes (1)
- measure
- Proportion of patients who are free of breast cancer.
- timeFrame
- 10 years
- description
- Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
Secondary outcomes (1)
- measure
- Local recurrance rate with acute toxicity and cosmetic evaluations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer * Patient agrees to evaluation of the axilla with sentinel lymph node biopsy * Post-menopausal women age \> 60, defined as women who have experienced no menstrual period in the past 12 months. * BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\] * Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria) * Grade 1, 2 acceptable * Associated LCIS is allowed * Estrogen receptor (ER) status of positive * Negative margins at ink on gross pathologic examination * Patient is node-negative, defined as N0 (i-) or N0 (i+) * Patient must be deemed functionally and mentally competent to understand and sign the informed consent Exclusion Criteria: * Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years * Immuno-compromised status * Pregnancy * Women with an active connective tissue disorder (i.e. scleroderma, lupus and others) * Breast cancer that involves the skin or chest wall, locally advanced breast cancer * Pure DCIS, all grades * Invasive lobular carcinoma * Evidence of lymphovascular invasion (LVI) * Invasive carcinoma with extensive intraductal component (EIC) * Neoadjuvant chemotherapy indicated * Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection * Not eligible for breast conserving management, i.e., prior whole breast radiation therapy * Estrogen receptor negative * Her2 positive * Grade 3
References
Publications (0)
Data not yet available
No reference posted for this study.