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Keep this study
Lead
Duke University
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 cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped for evaluation and consideration of revision. If at most one DLT is observed then escalation continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of irradiation.
Age
55–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
