Stereotactic Radiation for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of stereotactic radiation therapy for treating breast cancer. It focuses on patients with specific types of early-stage breast cancer, such as ductal carcinoma in situ or certain invasive types, who have undergone lumpectomy (breast-conserving surgery). Ideal participants have breast cancer in a single location and have had surgery with clear margins, meaning no cancer cells at the edge of the removed tissue. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking any hormonal agents like raloxifene, tamoxifen, or other selective estrogen receptor modulators before joining. If you're on endocrine therapy, you must stop it at least 28 days before starting the study.
What prior data suggests that Stereotactic Radiation is safe for breast cancer?
Research has shown that stereotactic radiation is generally safe for breast cancer patients. One study found that patients with a small number of cancer spread areas did not experience serious side effects, indicating that the radiation doses were well-tolerated. Another study found stereotactic radiation to be a safe option for treating oligometastatic breast cancer, reporting high success in controlling the cancer, meaning it did not grow or spread in the treated area. Overall, these findings suggest that stereotactic radiation is a reliable and safe option for patients, with no major safety concerns reported in these studies.12345
Why do researchers think this study treatment might be promising?
Stereotactic Radiation for breast cancer is unique because it delivers a highly focused, high-dose of radiation in just a single session. Unlike traditional radiation therapy, which often requires multiple sessions spread over several weeks, this method aims to minimize damage to surrounding healthy tissue while potentially speeding up treatment time. Researchers are excited because this precise approach could lead to fewer side effects and a more convenient treatment schedule for patients, making it a promising alternative to conventional radiation therapy options.
What evidence suggests that stereotactic radiation might be an effective treatment for breast cancer?
Research has shown that stereotactic radiation, the treatment under study in this trial, can effectively treat certain cancers. Studies have found that it controls cancer in the treated area 94.7% of the time. One study found that 85.4% of patients were still alive one year after treatment, which is encouraging. Additionally, 51.4% of patients experienced no worsening of their cancer, meaning it did not grow or spread. This suggests that stereotactic radiation might help manage breast cancer by preventing progression.16789
Who Is on the Research Team?
Asal Rahimi, MD
Principal Investigator
UTSW Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with early-stage breast cancer (stage 0, I, or II) who've had a lumpectomy with clear margins and no tumor larger than 3 cm. Participants must be disease-free from other cancers for at least a year, able to consent, not pregnant or breastfeeding, and willing to use contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive a single fraction of stereotactic body partial breast irradiation using the Cyberknife system
Follow-up
Participants are monitored for safety, effectiveness, and cosmesis after radiation treatment
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Radiation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor