Accelerated Partial Breast Irradiation for Early Stage Breast Cancer
(APBI RISE Trial)
Trial Summary
Do I need to stop taking my current medications for this trial?
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 to get a clear answer based on your specific situation.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that any prior treatment with radiation therapy or hormonal therapy for the currently diagnosed breast cancer is not allowed before enrollment. It's best to discuss your current medications with the trial team.
What data supports the idea that Accelerated Partial Breast Irradiation for Early Stage Breast Cancer is an effective treatment?
The available research shows that Accelerated Partial Breast Irradiation (APBI) is an effective treatment for early-stage breast cancer. A systematic review and meta-analysis of 8653 women in eight randomized trials found that APBI allows treatment in a shorter time and smaller area compared to whole-breast irradiation (WBI). A single institution study with an 8-year follow-up reported that APBI addresses the disadvantages of longer treatment times and unnecessary radiation associated with WBI. Additionally, a study on APBI using a 5-fraction prone technique showed positive long-term outcomes. Another study highlighted that APBI is a safe, effective, and convenient option for many women with early-stage breast cancer. Finally, early Australian experience with APBI reported good to excellent cosmetic results and no local or systemic cancer spread in patients followed for over three years.12345
What data supports the effectiveness of the treatment Accelerated Partial Breast Irradiation for early-stage breast cancer?
Research shows that Accelerated Partial Breast Irradiation (APBI) is effective for early-stage breast cancer, offering similar outcomes to whole-breast irradiation (WBI) but with a shorter treatment time and smaller radiation area. Studies report good cosmetic results and no significant increase in cancer recurrence, making it a safe and convenient option for many women.12345
What safety data is available for accelerated partial breast irradiation (APBI) in early stage breast cancer?
Several studies provide safety data for accelerated partial breast irradiation (APBI) in early stage breast cancer. A single institution study with an 8-year follow-up compared locoregional recurrence rates between APBI and whole breast irradiation (WBI), suggesting APBI as a viable option. A 5-year phase 3 trial showed non-inferiority of APBI compared to WBI in low-risk patients. Patient-reported outcomes indicate APBI is well-tolerated with manageable acute toxicity. A systematic review and meta-analysis of 8653 women across eight trials further supports the safety and effectiveness of APBI. Overall, APBI is considered a safe, effective, and convenient treatment for early stage breast cancer.12467
Is accelerated partial breast irradiation (APBI) safe for humans?
Accelerated partial breast irradiation (APBI) has been shown to be a well-tolerated treatment option for early-stage breast cancer, with studies reporting on patient-reported outcomes and acute toxicity. It is considered safe and effective, especially for women over 40 who have undergone breast-conserving surgery.12467
Is Accelerated Partial Breast Irradiation a promising treatment for early stage breast cancer?
Yes, Accelerated Partial Breast Irradiation (APBI) is a promising treatment for early stage breast cancer. It allows treatment to be completed in a shorter time, often just five days, compared to the longer traditional methods. This makes it more convenient and accessible for many women, especially those who might face challenges with longer treatment schedules. APBI has been shown to be safe and effective, offering a good option for women who have had a lumpectomy and meet certain criteria.12489
How is Accelerated Partial Breast Irradiation (APBI) different from other breast cancer treatments?
Accelerated Partial Breast Irradiation (APBI) is unique because it targets only the part of the breast where cancer was removed, allowing treatment to be completed in just five days, compared to the longer six-week course of whole-breast irradiation (WBI). This shorter treatment time can make it more convenient and accessible for women, especially those who face challenges with time and travel.12489
What is the purpose of this trial?
This study will use an adjuvant radiation therapy regimen called APBI (accelerated partial breast irradiation). APBI is a treatment option available to women considered to have an early stage, low-risk breast cancer. The standard external beam-based APBI treatment delivers treatments every other day for five treatments, over ten calendar days. The APBI in this study is modified and will deliver five once daily treatments over consecutive treatment days, with a slightly lower dose of radiation each day as compared to the standard external beam-based APBI treatment.
Research Team
Ryan Nowak, MD
Principal Investigator
Sanford Health
Eligibility Criteria
This trial is for women over 50 with early-stage, low-risk breast cancer who've had a lumpectomy. They must not be pregnant, agree to birth control during treatment, and have no history of certain breast cancers or treatments. The tumor should be small, unifocal without aggressive features, and they should have a life expectancy of at least 5 years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a novel IMRT/VMAT-based accelerated partial breast irradiation regimen with five once daily treatments over consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment with yearly mammograms and breast exams
Treatment Details
Interventions
- Accelerated Partial Breast Irradiation
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?
Sanford Health
Lead Sponsor
University of North Dakota
Collaborator