An interventional study of Intra-Operative Radiotherapy (IORT) and Lumpectomy in Breast Cancer and Carcinoma, Ductal, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 121 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
lumpectomy with accelerated partial breast irradiation
Radiation: Intra-Operative Radiotherapy (IORT) · Procedure: Lumpectomy · Radiation: Intracavitary Brachytherapy · Radiation: Accelerated External Beam 3-D Conformal Radiotherapy · Radiation: Stereotactic APBI
lumpectomy and whole breast irradiation
Procedure: Lumpectomy · Radiation: Whole Breast Radiotherapy
single dose in the operating room after lumpectomy
six and a half week treatment
5 day treatment
Also known as: MammoSite
5 day treatment
4 day treatment
In-breast tumor recurrence (IBTR)
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
Time frame: 20 years
Plan to share: No
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Stanford University