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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Brown University
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University Identifier:
First received: October 10, 2013
Last updated: April 25, 2016
Last verified: April 2016
To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Condition Intervention Phase
Breast Cancer
Device: Accuboost APBI
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Brown University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Rate of ipsilateral breast local recurrence [ Time Frame: annually for 2 years post treatment ]

Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accuboost APBI
28Gy delivered in 5 daily fractions
Device: Accuboost APBI
28Gy delivered in 5 daily fractions

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

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01961531

Contact: Kristen M Mitchell 4018633000

United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Kristen M Mitchell, CCRP    401-863-3000      
Principal Investigator: Catherine Yashar, MD         
United States, Florida
Watson Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Kristen Mitchell, EdM    401-863-3000   
Principal Investigator: Sandra Sha, MD         
United States, Illinois
Cancer Treatment Centers of America Withdrawn
Zion, Illinois, United States, 60099
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kristen M Mitchell    401-863-3000   
Principal Investigator: Jaroslaw Hepel, MD         
Sponsors and Collaborators
Brown University
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
  More Information

Responsible Party: Jaroslaw Hepel, Principal Investigator, Brown University Identifier: NCT01961531     History of Changes
Other Study ID Numbers: 291
Study First Received: October 10, 2013
Last Updated: April 25, 2016

Keywords provided by Brown University:
Invasive breast carcinoma processed this record on April 24, 2017