Actively Recruiting
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-05-23
90
Participants Needed
1
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and HIPAA authorization
- Women aged 65 years or older with new invasive breast cancer
- Tumor stage pT1
- Estrogen and progesterone receptor positive (≥10% by immunohistochemistry)
- HER2 negative by ASCO/CAP guidelines
- Tumor grade 1 or 2
- No lymph node involvement (N0)
- No lymphovascular space invasion
- Surgical margins at least 2 mm
- Completed breast conserving surgery with or without lymph node biopsy or dissection
- Suitable for accelerated partial breast irradiation as determined by radiation oncologist
- Prior or concurrent cancers allowed if they do not interfere with treatment or safety
- Participation in other trials allowed if no interference with this study
You will not qualify if you...
- Receiving pre- or post-operative systemic chemotherapy during study
- Currently on anti-hormonal agents (must stop within 30 days before randomization if previously used)
- Using hormonal replacement therapy (must stop within 30 days before randomization)
- Multifocal or multicentric breast tumors
- Tissue rearrangement in lumpectomy area
- Synchronous bilateral breast cancer
- Evidence of distant metastases
- Prior radiation to breast or chest area
- Autoimmune conditions increasing radiation risks
- Poor medical risk from uncontrolled conditions making hormonal or radiation therapy unsafe
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
L
Lori Stravers
CONTACT
J
Jessica Buddenbaum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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