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Brachytherapy
Targeted Radiotherapy for Early Stage Breast Cancer (APBI Trial)
Phase 2
Waitlist Available
Led By Dennis Carter, MD
Research Sponsored by Rocky Mountain Cancer Centers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have negative surgical margins (> or = 2 mm) after final surgery
Be a Tis, T1, N0, M0 AJC Classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-15 years
Awards & highlights
APBI Trial Summary
This trial shows that using a device to target radiation at the area where the cancer was removed, along with a type of radiation that better conforms to the shape of the breast, is safe and effective in patients with early stage breast cancer.
Who is the study for?
This trial is for early-stage breast cancer patients who've had a lumpectomy. They should have no cancer spread beyond the initial tumor site and clear surgical margins of at least 2mm. It's not for pregnant or breastfeeding women, those with collagen-vascular disease, or inadequate surgical margins.Check my eligibility
What is being tested?
The study compares two types of targeted radiation therapy after lumpectomy in breast cancer: Mammosite RTS Breast Brachytherapy and Intensity Modulated Radiotherapy to see if they're safe and effective.See study design
What are the potential side effects?
Possible side effects include skin irritation, fatigue, breast pain, swelling, infection risk at the treatment site, and rare cases of more severe skin reactions.
APBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last surgery removed all visible cancer with a clear margin of 2mm or more.
Select...
My cancer is in the very early stages and hasn't spread.
APBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cause specific survival
Disease free survival
Ipsilateral breast failure
+1 moreSecondary outcome measures
Serious Adverse device-related Events
APBI Trial Design
2Treatment groups
Experimental Treatment
Group I: MammositeExperimental Treatment1 Intervention
Accelerated Partial Breast Irradiation using Mammosite RTS
Group II: IMRTExperimental Treatment1 Intervention
Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiotherapy
2016
N/A
~30
Find a Location
Who is running the clinical trial?
Rocky Mountain Cancer CentersLead Sponsor
7 Previous Clinical Trials
1,218 Total Patients Enrolled
1 Trials studying Breast Cancer
660 Patients Enrolled for Breast Cancer
Charles Leonard, MDUNKNOWN
Dennis Carter, MDPrincipal InvestigatorRocky Mountain Cancer Centers
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My MRI showed multiple areas of concern in my breast, which were checked with an ultrasound and, if needed, a biopsy.My last surgery removed all visible cancer with a clear margin of 2mm or more.My cancer is in the very early stages and hasn't spread.I have cancerous or potentially cancerous calcifications.I had a breast MRI that confirmed my cancer is in an early stage.You have a collagen-vascular disease.There should be at least 7 millimeters of space between the balloon and your skin.My cancer surgery did not remove all the cancer; some was left very close to the edge.
Research Study Groups:
This trial has the following groups:- Group 1: Mammosite
- Group 2: IMRT
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.
How many venues are currently overseeing this research?
"On-going enrollment is available at 6 trial sites, including locations in Denver, Littleton and Lone Tree. To limit the burden of travel on participants, it's encouraged to select a local site if possible."
Answered by AI
Is this testing phase currently enrolling participants?
"As indicated by clinicaltrials.gov, the recruitment process for this medical trial has been concluded as it was last updated on July 10th 2013. Nonetheless, there are 2596 other studies employing patient participation at present."
Answered by AI
Has Intensity Modulated Radiotherapy been sanctioned by the FDA?
"The safety of Intensity Modulated Radiotherapy received a rating of 2 on our scale due to the fact that it is currently in Phase 2 trials, meaning there are some data sets demonstrating its security but no evidence yet for efficacy."
Answered by AI
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