Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

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

Trial Details

NCT ID
NCT05472792
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Accelerated Partial Breast Irradiation (APBI)
  • tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

  • Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health in…
  • Women greater than or equal to age 65 years with de novo invasive carcinoma of breast.
  • Pathological T1 (pT1) stage
  • Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining)

For full eligibility, visit ClinicalTrials.gov.

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