Status:
WITHDRAWN
BrUOG 351: PRE-OPERATIVE APBI USING NIBB
Lead Sponsor:
Jaroslaw Hepel
Collaborating Sponsors:
Brown University
Rhode Island Hospital
Conditions:
Breast Cancer
Invasive Breast Cancer
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing br...
Eligibility Criteria
Inclusion
- Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
- Age greater or equal to 60 years old;
- Life expectancy \> 6 months;
- Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
- Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN0.
- Tumor size by imaging ≤ 2cm; (Tis or T1)
- Estrogen receptor positive if invasive disease (DCIS can be ER negative);
- Her2neu negative if invasive disease;
- Nuclear Grade 1 or 2 if invasive disease (DCIS can be Grade 3);
- ECOG performance status of 0-2 (Appendix 1);
- Informed consent signed.
Exclusion
- Excisional biopsy or ipsilateral breast surgery within 6 months;
- Invasive lobular histology;
- Definitive LVSI on biopsy;
- Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
- Paget's disease of the nipple
- Distant metastases;
- Known BRCA 1/2 Mutation
- Active lupus or scleroderma,;
- Psychiatric or addictive disorder that would preclude attending follow-up;
- Neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted);
- Breast Implants;
- Tumor not well visualized on AccuBoost imaging;
- Breast separation with compression \> 8cm at time of simulation.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03437915
Start Date
March 1 2019
End Date
January 21 2020
Last Update
March 9 2021
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