CompletedNot Applicable

BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

United States40 participantsStarted 2014-07-24

Plain-language summary

To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Age range50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
✕. Active lupus or scleraderma;
✕. Pregnancy;
✕. 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);
✕. pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered node negative and are not excluded);
✕. Multicentric disease;

Number of Patients With Any Toxicity Related to the Radiation Treatment

Timeframe: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years

NCT IDNCT01961531

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10-26

Results submitted2020-01-27