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

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ClinicalTrials.gov Identifier: NCT01961531
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Results First Posted : August 25, 2020
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University

Tracking Information
First Submitted Date  ICMJE October 10, 2013
First Posted Date  ICMJE October 11, 2013
Results First Submitted Date  ICMJE January 27, 2020
Results First Posted Date  ICMJE August 25, 2020
Last Update Posted Date November 3, 2021
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Number of Patients With Any Toxicity Related to the Radiation Treatment [ Time Frame: during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years ]
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Number of Participants With Ipsilateral Breast Local Recurrence [ Time Frame: annually for 2 years post treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
Rate of ipsilateral breast local recurrence [ Time Frame: annually for 2 years post treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)
Official Title  ICMJE BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)
Brief Summary 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Accuboost APBI
28Gy delivered in 5 daily fractions
Study Arms  ICMJE Experimental: Accuboost APBI
28Gy delivered in 5 daily fractions
Intervention: Device: Accuboost APBI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 10, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date October 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01961531
Other Study ID Numbers  ICMJE 291
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaroslaw Hepel, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • Watson cancer center
  • Cancer Treatment Centers of America
  • University of California, San Diego
Investigators  ICMJE
Principal Investigator: Jaroslaw Hepel, M.D. Brown University
PRS Account Brown University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP