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Radiation Therapy
Pre-Surgery Radiation for Early-Stage Breast Cancer
N/A
Waitlist Available
Led By Sasha Beyer, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks post-apbi
Awards & highlights
No Placebo-Only Group
Summary
This trial studies radiation therapy given before surgery to reduce tumor size and minimize tissue removal in older patients with early breast cancer.
Who is the study for?
This trial is for women over 50 with stage I breast cancer that's hormone responsive and hasn't spread. They must be able to have an MRI, lie prone during treatment, and agree to surgery after radiation. Excluded are those with large tumors (>3cm), prior breast treatments, or certain other cancers within the last 5 years.
What is being tested?
The study tests if giving a high-dose radiation therapy called intensity-modulated accelerated partial breast irradiation (APBI) before surgery can shrink tumors more effectively while sparing healthy tissue in older patients with early-stage hormone-positive breast cancer.
What are the potential side effects?
Potential side effects of APBI may include skin irritation, fatigue, pain or discomfort at the treatment site, changes in breast size or shape, and rare risks associated with anesthesia during subsequent surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 weeks post-apbi
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks post-apbi
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
Secondary study objectives
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (image-guided intensity-modulated APBI)Experimental Treatment4 Interventions
Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapeutic conventional surgery
2003
Completed Phase 3
~12900
accelerated partial breast irradiation
2009
N/A
~190
image-guided radiation therapy
2008
Completed Phase 2
~180
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,233 Total Patients Enrolled
23 Trials studying Breast Cancer
2,902 Patients Enrolled for Breast Cancer
Sasha Beyer, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
4 Total Patients Enrolled
Julia White, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
4 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Breast cancer that does not respond to hormone treatment.You are planning to have a mastectomy.You are able to undergo an MRI with a special dye called contrast.You don't want to receive hormone therapy.A core biopsy shows breast cancer with positive estrogen or progesterone receptors.You have received radiation therapy on your chest or breast before.You have a type of breast cancer that is not epithelial, such as sarcoma or lymphoma.Your tissue sample must test negative for HER2 according to current ASCO/CAP guidelines.You have advanced stage breast cancer.You are younger than 50 years old.You must be able to lie on your stomach with your arms stretched out in front of you.You have Paget's disease affecting the nipple.A clip must have been placed at the biopsy site.The disease must be in one specific location on the mammogram or MRI.You have cancer in more than one area of your breast that are far apart from each other.You have suspicious areas in your breasts that have not been tested and confirmed to be harmless.You must be 50 years old or older.You have cancer that has spread to nearby lymph nodes.You need to have a test done to check for estrogen and progesterone receptors in a sample of your tissue.You have early stage breast cancer without spread to the lymph nodes.You can join the study if you had cancer before, but it's been at least 5 years since you were treated and your doctor thinks the cancer is unlikely to come back. If you had certain types of early-stage cancers like cervical, colon, skin, or melanoma, you can join the study if you were treated within the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (image-guided intensity-modulated APBI)
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.
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