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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2021-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation

AccuBoost APBI- 34.0 Gy in 10fx

Group Type EXPERIMENTAL

Accelerated partial breast irradiation

Intervention Type RADIATION

Accuboost APBI 34.0 Gy in 10 fractions

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.

Group Type EXPERIMENTAL

Extended Follow up

Intervention Type OTHER

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.

Interventions

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Accelerated partial breast irradiation

Accuboost APBI 34.0 Gy in 10 fractions

Intervention Type RADIATION

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No