N/A
Completed N=40
BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)
Source: ClinicalTrials.gov NCT01961531 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Patients With Any Toxicity Related to the Radiation Treatment — 40 Participants
Summary
To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Any Toxicity Related to the Radiation Treatment |
40 | — |
| SECONDARY Number of Participants With Ipsilateral Breast Local Recurrence |
2 | — |
Eligibility Criteria
Inclusion Criteria
- A confirmed histological diagnosis of invasive breast carcinoma or DCIS;
- Age greater or equal to 50 years old;
- Life expectancy > 6 months;
- Treated by breast conserving surgery
- Pathologic lymph node negative, which includes (pN0 i-, i+);
Patients, who are at very low risk for sentinel node involvement and sentinel node biopsy is not performed, are eligible if the treating investigator documents clinically lymph node negative (cN0). These patients include:
- DCIS
- Microinvasion only
- Pure tubular or mucinous histology
- Patients ≥ 70yo with T1a-T1c; estrogen receptor +
- Pathologic tumor size
- less than or equal to 2 cm for invasive disease;
- less than or equal to 3 cm for DCIS;
- Estrogen receptor positive if invasive disease (DCIS can be ER negative)
- Negative surgical margins greater than or equal to 2 mm. A margin of 8cm at time of simulation.
Data sourced from ClinicalTrials.gov (NCT01961531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.