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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:12/27/2018
Start Date:August 2011
End Date:May 2019

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ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

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.


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.
We found this trial at
4
sites
Providence, Rhode Island 02903
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Providence, RI
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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Lakeland, FL
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Tacoma, Washington
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Tacoma, WA
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