Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01463007
- Run by
- Jaroslaw Hepel
- People needed
- 40
- Starts
- 2011-08-01
- Expected to finish
- 2021-04-06
- Last updated by the study team
- 2021-05-19
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Center For Cancer Care and Research- Watson Clinic — Lakeland, Florida, United States
- Brown University Oncology Research Group — Providence, Rhode Island, United States
- Lifespan Hospitals — Providence, Rhode Island, United States
- Tacoma Radiation — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.