Accelerated Partial Breast Irradiation (APBI) for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina, Chapel Hill, NC
Breast Cancer+2 More
Accelerated Partial Breast Irradiation (APBI) - Radiation
Eligibility
65+
Female
What conditions do you have?
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Study Summary

The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size <2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

Eligible Conditions

  • Quality of Life (QOL)
  • Breast Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 5 years

1 year
Patient reported outcomes assessed by EORTC QLQ-BR45
Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
5 years
Disease-free survival
Endocrine therapy adherence
Overall survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Endocrine Therapy
1 of 2
Accelerated Partial Breast Irradiation (APBI)
1 of 2
Active Control
Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Accelerated Partial Breast Irradiation (APBI) · No Placebo Group · Phase 2

Accelerated Partial Breast Irradiation (APBI)
Radiation
Experimental Group · 1 Intervention: Accelerated Partial Breast Irradiation (APBI) · Intervention Types: Radiation
Endocrine Therapy
Drug
ActiveComparator Group · 1 Intervention: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Trial Background

Prof. Dana Lynne Casey, Assistant Professor- Department of Radiation Oncology
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Closest Location: University of North Carolina · Chapel Hill, NC
Photo of University of North Carolina at Chapel Hill  1Photo of University of North Carolina at Chapel Hill  2Photo of University of North Carolina at Chapel Hill  3
2007First Recorded Clinical Trial
18 TrialsResearching Breast Cancer
373 CompletedClinical Trials

Eligibility Criteria

Age 65+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 65 years of age or older.
You have a pathological T1 (pT1) stage of the tumour.
You have a tumor grade of 1 or 2.
You have no evidence of lymphovascular space invasion.
You have a final surgical margin of 2 mm or more.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.