Study of Stereotactic Radiotherapy for Breast Cancer (NCT03043794) | Clinical Trial Compass
TerminatedPhase 2
Study of Stereotactic Radiotherapy for Breast Cancer
Stopped: PI closed. Unable to enroll enough patients to collect and analyze data.
United States4 participantsStarted 2017-08-01
Plain-language summary
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Who can participate
Age range50 Years – 100 Years
SexFEMALE
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Inclusion Criteria:
* Female sex
* Age \> or = to 50 years of age
* Invasive ductal carcinoma
* Clinically and radiographically T1 tumor
* Clinically node negative
* Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
* Planning breast conserving surgery including sentinel node biopsy
* ≥10% expression of ER and/or PR
* HER2- using the current College of American Pathologists guidelines
* Post-menopausal
* Willing and able to provide informed consent
Exclusion Criteria:
* Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
* Pure DCIS without invasive cancer
* Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
* Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
* Positive pregnancy test
* Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
* Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
* Planning mastectomy
* Unable to tolerate prone positioning
What they're measuring
1
Treatment Response Measured by Residual Cancer Burden (RCB)
Timeframe: 4-6 weeks
Trial details
NCT IDNCT03043794
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins