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Radiation Therapy
SBRT for Early Stage Breast Cancer
Phase 2
Waitlist Available
Led By Rachel Blitzblau, MD PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
Breast preservation candidates with specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion estimated to be 5-10 years
Awards & highlights
Study Summary
This trial will test whether a single, preoperative dose of 21Gy is safe and effective for a larger group of subjects. The primary outcome measure is physician-reported rates of good/excellent cosmesis.
Who is the study for?
This trial is for women aged 60+ or those 50-59 with a low Oncotype score, diagnosed with early-stage breast cancer (ER+, HER2-) that's less than or equal to 2cm. They must have normal blood counts, be candidates for breast preservation, and agree to use contraception if of child-bearing potential. It excludes HER2 positive patients, those who've had neoadjuvant chemotherapy, pregnant women, and anyone unable to undergo the treatment due to medical conditions.Check my eligibility
What is being tested?
The study tests preoperative single-fraction radiotherapy delivering 21Gy in one session for early-stage breast cancer patients. The goal is to assess cosmetic outcomes using the NRG cosmesis scale at various intervals post-treatment up to three years.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from radiotherapy may include skin changes like redness and irritation at the treatment site, fatigue during and after treatment sessions, and possible long-term cosmetic differences in the treated breast.
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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I am a candidate for breast-saving surgery.
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I am 60 or older, or between 50-59 with a low cancer risk score.
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My cancer is estrogen receptor positive and HER2 negative.
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My kidney function is good enough for an MRI with contrast.
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My breast cancer is early stage and smaller than or equal to 2cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion estimated to be 5-10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion estimated to be 5-10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physician reported rates of good/excellent cosmesis.
Secondary outcome measures
Assess the impact of RT on circulating cell free DNA
Ki-67 will be assessed as a measure of tumor response
Local control in the treated breast relative to historic controls
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single arm 21Gy stereotactic radiotherapyExperimental Treatment1 Intervention
Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,407,766 Total Patients Enrolled
53 Trials studying Breast Cancer
9,883 Patients Enrolled for Breast Cancer
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,502 Total Patients Enrolled
5 Trials studying Breast Cancer
283 Patients Enrolled for Breast Cancer
Rachel Blitzblau, MD PhDPrincipal InvestigatorDuke Health
3 Previous Clinical Trials
49 Total Patients Enrolled
3 Trials studying Breast Cancer
49 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is estrogen receptor positive and HER2 negative.My cancer is HER2 positive.I did not have a clip placed during my biopsy and I do not want one now.Your treatment plan cannot be followed.Tissue samples from other hospitals will be checked again to confirm the diagnosis.Your white blood cell count, hemoglobin level, and platelet count must be within certain ranges when you agree to participate in the study.I have received chemotherapy before surgery.I have health issues that could affect my surgery's appearance.I cannot lie flat on my stomach due to my body shape or other reasons.Not enough breast images to determine the stage of the disease.I have been diagnosed with a type of breast cancer.I am a candidate for breast-saving surgery.I am 60 or older, or between 50-59 with a low cancer risk score.My kidney function is good enough for an MRI with contrast.You are pregnant according to a blood test.My breast cancer is early stage and smaller than or equal to 2cm.You have a breast implant in the breast that needs treatment with SBRT.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm 21Gy stereotactic radiotherapy
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.
Has this remedy earned authorization from the FDA?
"In light of the incomplete safety data and lack of efficacy evidence, our team at Power has provisionally rated this treatment's safety as a 2."
Answered by AI
Are there still opportunities for individuals to participate in this experiment?
"As per clinicaltrials.gov, this trial has since closed its recruitment window - the initial post was published on October 21st 2015 and edited lastly on March 16th 2022. Despite being inactive presently, there are over 2,500 trials that are still actively recruiting patients."
Answered by AI
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