Study of Stereotactic Radiotherapy for Breast Cancer
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Conditions:
🦠 Breast Cancer
🗓️ Study Start (Actual) 1 August 2017
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Washington, District of Columbia, United States
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 50 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2017
  • First Submitted that Met QC Criteria 3 February 2017
  • First Posted 6 February 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2023
  • Last Update Posted 31 May 2023
  • Last Verified May 2023