N/A
N=41
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01463007 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
Aug 2015
Primary outcome: Primary: Early and Intermediate Toxicity — 40; 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accelerated partial breast irradiation (Radiation); Extended Follow up (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Jaroslaw Hepel
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early and Intermediate Toxicity |
40; 28 | — |
| SECONDARY Cosmetic Outcome |
35 | — |
Summary
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
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 with axillary node dissection or sentinel lymph node biopsy
- Pathologic tumor size less than or equal to 2 cm
- Invasive ductal, mucinous, tubular or colloid histology
- Estrogen receptor positive for invasive carcinoma.
- Unifocal/unicentric disease
- Negative surgical margins greater than or equal to 2 mm
- Pathologic lymph node negative
- No evidence of lymphovascular invasion
- ECOG performance status of 0 or 1 (Appendix 1)
- Informed consent signed.
Exclusion Criteria
- Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
- Autoimmune disorder
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy;
- Extensive in situ carcinoma (EIC)
- Multicentric or multifocal disease
- Paget's disease of the nipple
- Distant metastases
- Lumpectomy cavity not well visualized on AccuBoost imaging
- Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
- Breast separation with compression > 7cm.
- Overlap of skin between orthogonal treatment axes.
Data sourced from ClinicalTrials.gov (NCT01463007). 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.