Study on Endocrine Therapy or Targeted Radiation After Lumpectomy for Low-Risk Breast Cancer in Women Over 65

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05472792

Provider View

This clinical trial is exploring two different treatments for women over 65 with low-risk breast cancer after lumpectomy: either targeted radiation therapy or hormone therapy. The study aims to compare the quality of life and cancer control between these two options.

Patient Parameters

Program Overview

The purpose of this study is to see how two different treatments affect quality of life and cancer outcomes in women over 65 with low-risk breast cancer who have had a lumpectomy. Participants will be randomly assigned to receive either targeted radiation therapy, called accelerated partial breast irradiation (APBI), or hormone therapy. APBI involves five sessions of radiation to the area where the tumor was removed, while hormone therapy involves taking medication for up to five years. The study will measure quality of life one year after surgery and compare the results between the two groups. Researchers believe that APBI might offer better quality of life while still effectively controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Women aged 65 or older with newly diagnosed invasive breast cancer.
  • Tumor size less than 2 cm, grade 1 or 2, and no cancer in the lymph nodes.
  • Cancer cells must be positive for estrogen and progesterone receptors.
  • HER2 negative according to specific medical guidelines.
  • No cancer spread to lymph or blood vessels.
  • Clear surgical margins of at least 2 mm after lumpectomy.
  • Completed breast-conserving surgery, with or without lymph node biopsy.
  • Suitable for targeted radiation therapy as determined by a radiation oncologist.
  • Can have other cancers if they don't interfere with this study.
  • Can participate in another clinical trial if it doesn't interfere with this one.

Exclusion Criteria

  • Cannot have chemotherapy before or after surgery while in this study.
  • Cannot be on hormone-blocking medications unless stopped 30 days before starting the study.
  • Cannot be on hormone replacement therapy unless stopped 30 days before starting the study.
  • Cannot have multiple tumors in the same or both breasts.
  • Cannot have had tissue rearrangement in the lumpectomy area.
  • Cannot have cancer in both breasts at the same time.
  • Cannot have signs of cancer spread to other parts of the body.
  • Cannot have had previous radiation to the breast or chest area.
  • Cannot have autoimmune conditions that increase radiation risks.
  • Cannot have uncontrolled medical conditions that make hormone or radiation therapy unsafe.

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