Ablative Pre-operative Radiation for Early Stage Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is pre-operative partial breast irradiation safe for early-stage breast cancer?
How is the Single Fraction Ablative Pre-operative Partial Breast Irradiation (S-PBI) treatment different from other treatments for early-stage breast cancer?
The Single Fraction Ablative Pre-operative Partial Breast Irradiation (S-PBI) is unique because it delivers a high dose of radiation in a single session before surgery, targeting only the part of the breast at high risk for cancer recurrence, unlike traditional treatments that involve multiple sessions of whole breast radiation after surgery.678910
What data supports the effectiveness of the treatment Ablative Pre-operative Radiation for Early Stage Breast Cancer?
Early studies suggest that pre-operative partial breast irradiation (PBI) can be safely used for early-stage breast cancer, showing similar local control and no increased side effects compared to traditional methods. This approach may also improve breast conservation rates and treatment compliance.3791011
Who Is on the Research Team?
Asal Rahimi, MD
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for women over 18 with early-stage breast cancer (tumors up to 3cm, not spread to skin or nodes) who haven't had surgery/chemo for it. They must be estrogen/progesterone receptor positive, Her2neu negative, and able to have an MRI or CEDM. Pregnant/lactating women, those with certain illnesses or a history of breast cancer/radiation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive single-fraction stereotactic partial breast radiotherapy with dose escalation to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety, cosmesis, and treatment response, including acute and late toxicity assessments
What Are the Treatments Tested in This Trial?
Interventions
- Radiomics on MRI
- Single Fraction Ablative Pre-operative Partial Breast (S-PBI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor