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Radiation Therapy
Accelerated Partial Breast Irradiation for Early Stage Breast Cancer (APBI RISE Trial)
N/A
Recruiting
Led By Ryan Nowak, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The tumor must be positive for either the presence of the estrogen or progesterone receptor, and either 0 or +1 for the HER-2/neu receptor on immunohistochemical staining
The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity to the whole breast reference volume ratio must be ≤ 30% based on the CT-simulation scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
APBI RISE Trial Summary
This trial tests a modified APBI regimen to treat early stage, low-risk breast cancer. It delivers daily radiation over 5 days, each with a slightly lower dose than usual.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a modified accelerated partial breast irradiation (APBI) regimen for treating favorable risk breast cancer. It involves five daily radiation treatments over consecutive days using IMRT/VMAT technology with lower doses compared to standard APBI.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from radiation therapy may include skin irritation at the treatment site, fatigue, mild swelling in the treated area, and changes in breast texture.
APBI RISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is positive for estrogen or progesterone and not strongly positive for HER2.
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The area treated by lumpectomy is clearly marked and is less than 30% of my breast size.
Select...
My cancer was surgically removed with clear margins and the tumor was small.
Select...
I have only one tumor.
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I am 50 years old or older.
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I can care for myself but may not be able to do any physical work.
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My breast cancer is either DCIS or invasive ductal carcinoma.
Select...
Radiation therapy is part of my treatment plan.
APBI RISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast
Secondary outcome measures
Acute Adverse Events
Disease
Late Adverse Events
+3 moreAPBI RISE Trial Design
1Treatment groups
Experimental Treatment
Group I: IMRT/VMAT-Based Accelerated Partial Breast IrradiationExperimental Treatment1 Intervention
Patients will be treated with a novel IMRT/VMAT-based accelerated partial breast irradiation regimen.
Find a Location
Who is running the clinical trial?
University of North DakotaOTHER
15 Previous Clinical Trials
1,127 Total Patients Enrolled
2 Trials studying Breast Cancer
178 Patients Enrolled for Breast Cancer
Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,832 Total Patients Enrolled
1 Trials studying Breast Cancer
1,550 Patients Enrolled for Breast Cancer
Ryan Nowak, MDPrincipal InvestigatorSanford Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Paget's disease of the nipple.I have a collagen vascular disease like SLE or scleroderma.My tumor is positive for estrogen or progesterone and not strongly positive for HER2.The area treated by lumpectomy is clearly marked and is less than 30% of my breast size.My breast cancer is grade 3.There are no signs of cancer spreading to the lymphatic or blood vessels.My breast cancer has not spread to the lymph nodes under my arm, confirmed by a biopsy.My cancer was surgically removed with clear margins and the tumor was small.My doctor believes I have 5 or more years to live, not counting my breast cancer.I am male.I have only one tumor.I am 50 years old or older.I had a lumpectomy for breast cancer, and clips may or may not have been used.I can care for myself but may not be able to do any physical work.I have a genetic risk for breast cancer.You have mental health or addiction issues that may make it hard for you to take part in the study.My breast cancer is either DCIS or invasive ductal carcinoma.I have had breast cancer or DCIS before, but not LCIS treated only with surgery.I have received radiation or hormonal therapy for my current breast cancer.I have suspicious lymph nodes near my breast without confirmed cancer.I have had radiation therapy on my chest or breast before.Radiation therapy is part of my treatment plan.My breast cancer is invasive lobular carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT/VMAT-Based Accelerated Partial Breast Irradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for potential participants in this trial?
"According to clinicaltrials.gov, this trial is actively enrolling participants at the present time. The original post was made on March 1st 2022 with the most recent update occurring November 11th of that same year."
Answered by AI
What is the upper limit of participants involved in this clinical research?
"Affirmative. Clinicaltrials.gov hosts data indicating that this medical trial is actively seeking enrollees, having been initiated on March 1st 2022 and most recently adjusted November 11th 2022. 91 participants are required at 3 healthcare facilities."
Answered by AI
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