Status:
COMPLETED
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Lead Sponsor:
Jaroslaw Hepel
Collaborating Sponsors:
The Miriam Hospital
Rhode Island Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01463007
Start Date
August 1 2011
End Date
April 6 2021
Last Update
May 19 2021
Active Locations (4)
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1
Center For Cancer Care and Research- Watson Clinic
Lakeland, Florida, United States, 33805
2
Brown University Oncology Research Group
Providence, Rhode Island, United States, 02903
3
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
4
Tacoma Radiation
Tacoma, Washington, United States, 98405-4250