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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 : Completed
First Posted : October 11, 2013
Results First Posted : August 25, 2020
Last Update Posted : March 4, 2022
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
Information provided by (Responsible Party):
Brown University

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

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Accuboost APBI Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 24, 2014
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Accuboost APBI
28Gy delivered in 5 daily fractions
Device: Accuboost APBI
28Gy delivered in 5 daily fractions

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of Participants With Ipsilateral Breast Local Recurrence [ Time Frame: annually for 2 years post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961531

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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
United States, Florida
Watson Cancer Center
Lakeland, Florida, United States, 33805
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Watson cancer center
Cancer Treatment Centers of America
University of California, San Diego
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Principal Investigator: Jaroslaw Hepel, M.D. Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT01961531    
Other Study ID Numbers: 291
First Posted: October 11, 2013    Key Record Dates
Results First Posted: August 25, 2020
Last Update Posted: March 4, 2022
Last Verified: February 2022
Keywords provided by Brown University:
Invasive breast carcinoma