Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: Accelerated partial breast irradiationOther: Extended Follow up
- Registration Number
- NCT01463007
- Lead Sponsor
- Jaroslaw Hepel
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation Accelerated partial breast irradiation AccuBoost APBI- 34.0 Gy in 10fx Extended Follow up Extended Follow up This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
- Primary Outcome Measures
Name Time Method Early and Intermediate Toxicity 2 years Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
- Secondary Outcome Measures
Name Time Method Cosmetic Outcome 2 years Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.
Trial Locations
- Locations (4)
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