Pre-Surgery Radiation for Early-Stage Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for treating early-stage breast cancer using a special type of radiation called Accelerated Partial Breast Irradiation (APBI) before surgery. The goal is to shrink the tumor and reduce the amount of normal tissue removed during surgery. It targets patients with stage I breast cancer sensitive to certain hormones (estrogen or progesterone). Candidates should have a single tumor that has not spread to lymph nodes and can tolerate lying face down for treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have had any prior treatment with radiation, chemotherapy, biotherapy, or hormone therapy for the current breast cancer before joining the study.
What prior data suggests that this radiation therapy is safe for early-stage breast cancer patients?
Research has shown that image-guided intensity-modulated accelerated partial breast irradiation (APBI) is safe for patients with early-stage breast cancer. In one study, results after three years indicated minimal early and late side effects from the radiation, meaning patients experienced few severe problems post-treatment. Additionally, the breast's appearance post-treatment was rated as excellent to good.
Another study compared this radiation therapy to the traditional method of treating the whole breast. The findings suggested that APBI is a good option for early breast cancer because it targets only the tumor area, helping to protect surrounding healthy tissue.
Overall, these studies suggest that APBI is well-tolerated. Participants experienced fewer side effects and maintained a good quality of life after treatment.12345Why are researchers excited about this trial?
Unlike traditional whole-breast radiation therapy that typically spans several weeks, the treatment of accelerated partial breast irradiation (APBI) offers a quicker option. This method delivers focused radiation to the part of the breast where cancer is most likely to return, cutting down the treatment duration to just 5-10 days. Researchers are excited about image-guided intensity-modulated APBI because it allows for precise targeting of the tumor site, potentially reducing exposure to surrounding healthy tissue and minimizing side effects. This targeted approach not only enhances convenience but also holds promise for maintaining the quality of life for patients undergoing treatment for early-stage breast cancer.
What evidence suggests that intensity-modulated accelerated partial breast irradiation is effective for early-stage breast cancer?
This trial will evaluate image-guided intensity-modulated accelerated partial breast irradiation (APBI) for early-stage breast cancer. Studies have shown that APBI can lead to fewer side effects and better breast appearance over time, effectively targeting cancer while protecting healthy tissue. Research supports intensity-modulated radiation therapy (IMRT) as a modern method that enhances the precision of radiation targeting cancer cells. Both techniques aim to shrink tumors and preserve more healthy tissue. These methods offer promising options for treating early-stage breast cancer, particularly in older patients with hormone-sensitive tumors.56789
Who Is on the Research Team?
Sasha Beyer, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for women over 50 with stage I breast cancer that's hormone responsive and hasn't spread. They must be able to have an MRI, lie prone during treatment, and agree to surgery after radiation. Excluded are those with large tumors (>3cm), prior breast treatments, or certain other cancers within the last 5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo image-guided intensity-modulated accelerated partial breast irradiation (APBI) twice daily in the prone position
Surgery
Participants undergo lumpectomy within 4-6 weeks post-APBI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Accelerated Partial Breast Irradiation
- Image-Guided Radiation Therapy
- Intensity-Modulated Radiation Therapy
- Therapeutic Conventional Surgery
Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:
- Early-stage breast cancer
- Ductal carcinoma in situ (DCIS)
- Stage I or II breast cancer
- Early-stage breast cancer
- Ductal carcinoma in situ (DCIS)
- Stage I or II breast cancer
- Early-stage breast cancer
- Ductal carcinoma in situ (DCIS)
- Stage I or II breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor