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Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer | Clinical Trials | Clareo Health

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

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

NCT01463007•Jaroslaw Hepel

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+3 more criteria

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)
+7 more criteria

Locations (4)

Center For Cancer Care and Research- Watson Clinic

Lakeland, Florida, United States

Brown University Oncology Research Group

Providence, Rhode Island, United States

Lifespan Hospitals

Providence, Rhode Island, United States

Tacoma Radiation

Tacoma, Washington, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

September 12, 2013

Completion Date

April 6, 2021

Last Updated

May 19, 2021

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Accelerated partial breast irradiation

RADIATION

Extended Follow up

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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