Clinical Trials /

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

NCT01961531

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)
  • Official Title: BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)

Clinical Trial IDs

  • ORG STUDY ID: 291
  • NCT ID: NCT01961531

Conditions

  • Breast Cancer

Purpose

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

Detailed Description

      The purpose of this study is to evaluate the rate of early and intermediate toxicity related
      to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction
      schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in
      women with resected, early stage breast cancer.

      Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation
      technology, has the potential to eliminate the disadvantages of the conventional APBI
      techniques. NIBB facilitates non-invasive partial breast irradiation without the use of
      catheters or implants. Yet by using breast immobilization and precise image-guidance, it
      reduces non-target breast tissue within the irradiated field compared with other non-invasive
      APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI.

      We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and
      effective modality to deliver partial breast irradiation.

      Anticipated advantages of NIBB protocol treatment include:

        -  Convenient treatment schedule

        -  Short course can allow for increased patient access to treatment

        -  Non-invasive approach

        -  Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging

        -  Reduced irradiation of non-target breast tissue

        -  Reduced skin toxicity

        -  No heart or lung radiation exposure

        -  Reduced late skin or breast toxicity

        -  High rate of good or excellent cosmetic outcome

        -  High rate of ipsilateral breast tumor control comparable to other APBI techniques
    

Trial Arms

NameTypeDescriptionInterventions
Accuboost APBIExperimental28Gy delivered in 5 daily fractions

    Eligibility Criteria

            Inclusion Criteria:
    
              1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS;
    
              2. Age greater or equal to 50 years old;
    
              3. Life expectancy > 6 months;
    
              4. Treated by breast conserving surgery
    
              5. Pathologic lymph node negative, which includes (pN0 i-, i+);
    
                 Patients, who are at very low risk for sentinel node involvement and sentinel node
                 biopsy is not performed, are eligible if the treating investigator documents
                 clinically lymph node negative (cN0). These patients include:
    
                   -  DCIS
    
                   -  Microinvasion only
    
                   -  Pure tubular or mucinous histology
    
                   -  Patients ≥ 70yo with T1a-T1c; estrogen receptor +
    
              6. Pathologic tumor size
    
                   1. less than or equal to 2 cm for invasive disease;
    
                   2. less than or equal to 3 cm for DCIS;
    
              7. Estrogen receptor positive if invasive disease (DCIS can be ER negative)
    
              8. Negative surgical margins greater than or equal to 2 mm. A margin of <2mm is
                 acceptable if at natural boundary, i.e. skin or pectoralis fascia.
    
              9. No lymphovascular invasion;
    
             10. ECOG performance status of 0-2 (Appendix 1);
    
             11. Informed consent signed.
    
            Exclusion Criteria:
    
              1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
    
              2. Active lupus or scleraderma;
    
              3. Pregnancy;
    
              4. Psychiatric or addictive disorder that would preclude attending follow-up;
    
              5. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted);
    
              6. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy
                 proven benign);
    
              7. pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered
                 node negative and are not excluded);
    
              8. Multicentric disease;
    
              9. Paget's disease of the nipple;
    
             10. Breast Implants
    
             11. Distant metastases;
    
             12. Lumpectomy cavity not well visualized on AccuBoost imaging;
    
             13. Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any
                 available applicator.
    
             14. Breast separation with compression > 8cm at time of simulation.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The primary objective is to evaluate the rate of early and intermediate toxicity.
    Time Frame:during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Rate of ipsilateral breast local recurrence
    Time Frame:annually for 2 years post treatment
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Brown University

    Trial Keywords

    • DCIS
    • IDC
    • Invasive breast carcinoma

    Last Updated

    May 23, 2017