Status:
COMPLETED
Single Dose Partial Breast Radiotherapy
Lead Sponsor:
Duke University
Conditions:
Breast Cancer
Eligibility:
FEMALE
55-80 years
Phase:
PHASE1
Brief Summary
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be performed within 3 weeks (...
Detailed Description
This study will assess the safety of partial breast radiosurgery as measured by the incidence of acute toxicity and wound healing complications in three dose cohorts. Patients will be enrolled in coh...
Eligibility Criteria
Inclusion
- Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in situ or invasive ductal (or other favorable histology) carcinoma of the breast
- Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
- Clinical T1N0M0
- 55 years of age or older
- Estrogen receptor (ER) positive,
- No evidence of lymphovascular space invasion on initial biopsy
- Not pregnant. If not post-menopausal must adhere to birth control measures
- White blood cell count \> 3000, Hemoglobin \> 9, platelets \>100000
- Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min
Exclusion
- Neoadjuvant chemotherapy
- Breast implants
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
- Patients unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
- HER-2/neu positive
- Positive serum pregnancy test
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00944528
Start Date
July 28 2010
End Date
March 25 2023
Last Update
October 27 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710