SBRT for Early Stage Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100).The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is SBRT generally safe for humans?
SBRT, also known as SABR, has been used safely in treating various cancers, including lung cancer, but some serious complications have been reported. The risk of severe side effects can increase when tumors are near sensitive areas like the bronchial tree. Strategies to reduce these risks are important to ensure safety.12345
How is the treatment SBRT different from other treatments for early-stage breast cancer?
SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to the tumor in a few sessions, making it a noninvasive option for patients who cannot undergo surgery. This approach is particularly novel for early-stage breast cancer, as it can effectively treat the cancer with minimal impact on surrounding healthy tissue.26789
What data supports the effectiveness of the treatment SBRT for early-stage breast cancer?
Stereotactic ablative radiotherapy (SABR), which is similar to SBRT, has shown effectiveness in treating early-stage lung cancer and oligometastatic breast cancer, suggesting it could be beneficial for early-stage breast cancer as well. It is known for precisely targeting tumors with high doses of radiation, improving tumor control and survival rates in other cancers.68101112
Who Is on the Research Team?
Rachel Blitzblau, MD PhD
Principal Investigator
Duke Health
Are You a Good Fit for This Trial?
This trial is for women aged 60+ or those 50-59 with a low Oncotype score, diagnosed with early-stage breast cancer (ER+, HER2-) that's less than or equal to 2cm. They must have normal blood counts, be candidates for breast preservation, and agree to use contraception if of child-bearing potential. It excludes HER2 positive patients, those who've had neoadjuvant chemotherapy, pregnant women, and anyone unable to undergo the treatment due to medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Radiotherapy
Participants receive a single fraction of 21Gy stereotactic radiotherapy before surgery
Surgery
Participants undergo surgery following radiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cosmesis and gene expression assessments
Long-term Follow-up
Annual clinical examination combined with breast imaging to assess local control
What Are the Treatments Tested in This Trial?
Interventions
- SBRT
SBRT is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Bone metastases
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
- Spinal tumors
- Prostate cancer
- Lung cancer
- Liver cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Gateway for Cancer Research
Collaborator