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 September 2014 by Brown University
Sponsor:
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University
ClinicalTrials.gov Identifier:
NCT01961531
First received: October 10, 2013
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of ipsilateral breast local recurrence [ Time Frame: annually for 2 years post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (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
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 have elected to forgo sentinel node biopsy, are eligible if clinically lymph nodes negative (cN0). These patients include:

    • DCIS
    • Microinvasion only
    • Pure tubular or mucinous histology
    • Patients ≥ 70yo with 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. Distant metastases;
  11. Lumpectomy cavity not well visualized on AccuBoost imaging;
  12. Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any available applicator.
  13. 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 ClinicalTrials.gov identifier: NCT01961531

Contacts
Contact: kayla Rosati 4018633000 kayla_rosati@brown.edu

Locations
United States, Florida
Watson Cancer Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Kayla Rosati, EdM    401-863-3000    kayla_rosati@brown.edu   
Principal Investigator: Sandra Sha, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: kayla rosati    401-863-3000    kayla_rosati@brown.edu   
Principal Investigator: Jaroslaw Hepel, MD         
Sponsors and Collaborators
Brown University
  More Information

No publications provided

Responsible Party: Jaroslaw Hepel, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01961531     History of Changes
Other Study ID Numbers: 291
Study First Received: October 10, 2013
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
DCIS
IDC
Invasive breast carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014