Study Comparing 5-Day vs. 9-Day Whole Breast Radiation with Boost for Early-Stage Breast Cancer

Sponsor: University of Utah

Sponsor score: 0

ClinicalTrials ID:NCT06961955

This clinical trial is exploring whether a 5-day or a 9-day course of whole breast radiation therapy is more effective for treating early-stage breast cancer. The study aims to determine the best duration for radiation treatment to help manage the disease.

Patient Parameters

Program Overview

The purpose of this study is to compare two different schedules of whole breast radiation therapy—5 days versus 9 days—to see which is more effective for patients with early-stage breast cancer. This research will help doctors understand the best way to deliver radiation therapy to improve outcomes for patients.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years or older.
  • Women over 50 must have at least one risk factor, such as high-grade cancer, low estrogen receptor positivity, lymphovascular invasion, close surgical margins, or extensive intraductal component.
  • Women 50 or younger do not need additional risk factors.
  • Confirmed diagnosis of invasive breast cancer or Ductal Carcinoma In Situ (DCIS).
  • Breast cancer stage T0-3, N0, M0, with whole breast radiation recommended by the doctor.
  • Lumpectomy performed within 84 days before starting radiation.
  • Good overall health with a performance status score of 2 or less.
  • Negative surgical margins from lumpectomy, except for a small positive margin at the chest wall.
  • Negative pregnancy test for women who can become pregnant, or proof of permanent sterilization or menopause.
  • Women of childbearing potential must use effective birth control during and for 30 days after radiation.
  • Willing to provide informed consent and follow study guidelines.

Exclusion Criteria

  • Cancer in both breasts.
  • Previous radiation therapy to the chest.
  • Previous chemotherapy.
  • Recurrent breast cancer.
  • Cancer that has spread to other parts of the body or lymph nodes.
  • Major chest surgery affecting study participation within 8 weeks before starting the study.
  • Previous breast cancer in either breast.
  • Any other cancer that may affect safety or participation in the study.
  • Uncontrolled serious health conditions, such as heart failure, recent heart attack, or stroke.
  • Significant complications after lumpectomy requiring additional surgery or hospital admission for antibiotics.
  • Certain types of breast cancer, like neuroendocrine carcinoma or sarcoma.
  • Conditions that make radiation therapy unsafe, like connective tissue disease.
  • Medical or psychological conditions that affect understanding or following the study.
  • Taking medications or therapies that increase sensitivity to radiation.

Locations

FACILITYZIPCITYSTATE
Huntsman Cancer Institute/University of Utah84112Salt Lake CityUtah

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