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Brachytherapy
Intra-operative Radiation Therapy for Breast Cancer
N/A
Waitlist Available
Led By Helena Chang, MD, PhD
Research Sponsored by Xoft, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline reported at 5 years
Awards & highlights
Study Summary
This trial is to see if a new cancer treatment is as effective as the current standard treatment.
Who is the study for?
This trial is for women over 40 with early-stage breast cancer (ductal carcinoma) that's less than 3 cm in size. They must not be pregnant or nursing, agree to use birth control, and have no history of certain breast cancers or treatments like chemotherapy before surgery. Women with pacemakers near the treatment area or autoimmune diseases can't join.Check my eligibility
What is being tested?
The study tests the Xoft Axxent eBx System for single-fraction IORT as a stand-alone radiation therapy compared to whole breast irradiation in treating early stage breast cancer during conserving therapy.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of intra-operative radiation therapy may include skin irritation, pain at the site, fatigue, and potential complications related to exposure of nearby tissues and organs to radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of breast cancer.
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My cancer is early stage and the tumor is small.
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My tumor is smaller than 3.0 cm in size.
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I am a woman aged 40 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on-going monitoring, report at 5 and 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on-going monitoring, report at 5 and 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
Secondary outcome measures
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years
Assess the rate of regional breast tumor recurrence (RBTR)
Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Intra-operative Radiation Therapy - IORTExperimental Treatment1 Intervention
Intra-operative Radiation Therapy
Find a Location
Who is running the clinical trial?
Icad, Inc.Industry Sponsor
4 Previous Clinical Trials
148 Total Patients Enrolled
Xoft, Inc.Lead Sponsor
10 Previous Clinical Trials
1,287 Total Patients Enrolled
3 Trials studying Breast Cancer
182 Patients Enrolled for Breast Cancer
Helena Chang, MD, PhDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received initial treatment with chemotherapy or hormone therapy for my current breast cancer.I have been diagnosed with a type of breast cancer.I am at high risk for breast-saving surgery or radiation during surgery.My cancer has spread to my lymph system or blood vessels.I have a BRCA 1 or 2 mutation.My cancer is early stage and the tumor is small.Both of my breast cancers qualify for the trial based on all required conditions.My tumor is smaller than 3.0 cm in size.I have invasive lobular cancer.I cannot undergo radiation therapy due to health risks.My breast cancer has come back in the same breast.I have breast cancer in more than one location in the same breast.My affected breast has been exposed to radiation before.I am a woman aged 40 or older.I have a pacemaker near where my breast cancer is located.I have been diagnosed with breast cancer in more than one area through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-operative Radiation Therapy - IORT
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.
In how many medical centers is the investigation into this treatment being conducted?
"This clinical trial is available in a total of 26 medical centres, which include Stuart, Baltimore and Fort Wayne. Given the necessity to attend regular appointments if recruited into this study, it is advisable for participants to select a clinic closest to them as possible."
Answered by AI
Does this clinical trial continue to accept participants?
"This clinical trial, originally posted on May 8th 2012 and last updated on March 30 2022, is not presently accepting applicants. However, 2533 other medical studies are currently recruiting patients."
Answered by AI
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