Clinical Trials /

Study of Stereotactic Radiotherapy for Breast Cancer

NCT03043794

Description:

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Stereotactic Radiotherapy for Breast Cancer
  • Official Title: A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response

Clinical Trial IDs

  • ORG STUDY ID: J1741
  • NCT ID: NCT03043794

Conditions

  • Breast Cancer

Purpose

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

Detailed Description

      This is a single arm phase II study design, evaluating the pathologic response (primary
      endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational
      correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to
      intact breast tumors in patients with hormone-receptor positive early stage breast cancer.
    

Trial Arms

NameTypeDescriptionInterventions
SBRT to the breast then surgeryExperimentalStereotactic Body Radiation of 21 gy followed by standard of care surgery

    Eligibility Criteria

            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
          
    Maximum Eligible Age:100 Years
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:response
    Time Frame:4-6 weeks
    Safety Issue:
    Description:To determine the rate of Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)) and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.

    Secondary Outcome Measures

    Measure:The rate of treatment-related toxicity
    Time Frame:90 days
    Safety Issue:
    Description:To determine the rate of severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery.
    Measure:The rate of cosmetic outcome
    Time Frame:90 days
    Safety Issue:
    Description:To determine the rate of poor cosmetic outcomes from both provider and patient perspectives up to 3 years after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images.
    Measure:The time to recurrence
    Time Frame:1 year
    Safety Issue:
    Description:To measure local recurrence rate
    Measure:Quality of Life
    Time Frame:1 year
    Safety Issue:
    Description:To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS)

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Trial Keywords

    • early stage
    • low risk

    Last Updated

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