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Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463007
First Posted: November 1, 2011
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Miriam Hospital
Rhode Island Hospital
Information provided by (Responsible Party):
Jaroslaw Hepel, Brown University
  Purpose
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

Condition Intervention
Breast Cancer Radiation: Accelerated partial breast irradiation Other: Extended Follow up

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

Resource links provided by NLM:


Further study details as provided by Jaroslaw Hepel, Brown University:

Primary Outcome Measures:
  • Early and Intermediate Toxicity [ Time Frame: 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 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.


Secondary Outcome Measures:
  • Cosmetic Outcome [ Time Frame: 2 years ]
    Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.


Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: December 2018
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation
AccuBoost APBI- 34.0 Gy in 10fx
Radiation: Accelerated partial breast irradiation
Accuboost APBI 34.0 Gy in 10 fractions
Experimental: Extended Follow up
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
Other: Extended Follow up
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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 with axillary node dissection or sentinel lymph node biopsy
  5. Pathologic tumor size less than or equal to 2 cm
  6. Invasive ductal, mucinous, tubular or colloid histology
  7. Estrogen receptor positive for invasive carcinoma.
  8. Unifocal/unicentric disease
  9. Negative surgical margins greater than or equal to 2 mm
  10. Pathologic lymph node negative
  11. No evidence of lymphovascular invasion
  12. ECOG performance status of 0 or 1 (Appendix 1)
  13. Informed consent signed.

Exclusion Criteria:

  1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
  2. Autoimmune disorder
  3. Pregnancy
  4. Breast implants
  5. Psychiatric or addictive disorder that would preclude attending follow-up
  6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
  7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
  8. Lobular features on histology (pure or mixed) or sarcoma histology
  9. Node positive on axillary dissection or in the sentinel lymph node biopsy;
  10. Extensive in situ carcinoma (EIC)
  11. Multicentric or multifocal disease
  12. Paget's disease of the nipple
  13. Distant metastases
  14. Lumpectomy cavity not well visualized on AccuBoost imaging
  15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
  16. Breast separation with compression > 7cm.
  17. Overlap of skin between orthogonal treatment axes.
  Contacts and Locations
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): NCT01463007


Locations
United States, Florida
Center For Cancer Care and Research- Watson Clinic
Lakeland, Florida, United States, 33805
United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Rhode Island Hospital
Providence, Rhode Island, United States, 02906
United States, Washington
Tacoma Radiation
Tacoma, Washington, United States, 98405-4250
Sponsors and Collaborators
Jaroslaw Hepel
The Miriam Hospital
Rhode Island Hospital
Investigators
Principal Investigator: Jaroslaw Hepel, MD Brown University Oncology Research Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaroslaw Hepel, principal investigator, Brown University
ClinicalTrials.gov Identifier: NCT01463007     History of Changes
Other Study ID Numbers: BrUOG 251
First Submitted: July 21, 2011
First Posted: November 1, 2011
Results First Submitted: June 24, 2015
Results First Posted: August 21, 2015
Last Update Posted: June 9, 2017
Last Verified: May 2017

Keywords provided by Jaroslaw Hepel, Brown University:
invasive ductal cancer
tubular breast cancer
breast cancer
colloid
ER positive
radiation

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