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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | 84112 | Salt Lake City | Utah |
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