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Radiation Therapy
Stereotactic Radiotherapy for Breast Cancer
Phase 2
Recruiting
Led By Jean Wright, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Invasive ductal carcinoma
Clinically and radiographically T1 tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether preoperative radiation to the breast may help low risk breast cancer.
Who is the study for?
This trial is for women over 50 with low-risk breast cancer, specifically invasive ductal carcinoma that's HER2- and clinically node negative. They must be post-menopausal, have a tumor visible on MRI, and plan to conserve the breast. Excluded are those with certain medical conditions like Lupus or rheumatoid arthritis, pregnant women, patients without a biopsy clip (unless they agree to placement), or those who can't meet radiation safety measures due to anatomy.Check my eligibility
What is being tested?
The study is testing preoperative stereotactic body radiation therapy (SBRT) in treating low risk breast cancer before surgery. It's designed for early-stage tumors and aims at seeing how well this focused form of radiation works as a preliminary treatment.See study design
What are the potential side effects?
While not explicitly listed here, side effects of SBRT may include skin redness, swelling or tenderness in the treated area, fatigue during treatment weeks and sometimes rib fractures or lung issues due to the high dose of targeted radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is invasive ductal carcinoma.
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My tumor is small and found early.
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My cancer tests show at least 10% ER or PR hormone receptor positivity.
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I am female.
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I have gone through menopause.
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My cancer is not HER2 positive according to the latest guidelines.
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My cancer has not spread to my lymph nodes.
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I plan to have surgery to remove my breast tumor but keep my breast, including a sentinel node biopsy.
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I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
response
Secondary outcome measures
Quality of Life
The rate of cosmetic outcome
The rate of treatment-related toxicity
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SBRT to the breast then surgeryExperimental Treatment1 Intervention
Stereotactic Body Radiation of 21 gy followed by standard of care surgery
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,059 Total Patients Enrolled
43 Trials studying Breast Cancer
4,938 Patients Enrolled for Breast Cancer
Jean Wright, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
121 Total Patients Enrolled
2 Trials studying Breast Cancer
109 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to undergo a mastectomy.My breast cancer is invasive ductal carcinoma.My tumor is small and found early.My cancer tests show at least 10% ER or PR hormone receptor positivity.I have a condition like Lupus, rheumatoid arthritis, or scleroderma.My tumor's location or my body's shape makes certain treatments not possible.I am female.You are pregnant.My breast cancer is non-invasive.I did not have a clip placed during my biopsy and I do not want one now.I have gone through menopause.I have a breast implant that will be removed before starting the study treatment.My cancer is not HER2 positive according to the latest guidelines.I am receiving or will receive drug treatments before surgery for my cancer.I cannot lie on my stomach comfortably.My cancer has not spread to my lymph nodes.I plan to have surgery to remove my breast tumor but keep my breast, including a sentinel node biopsy.I am 50 years old or older.My MRI shows a clearly outlined tumor.
Research Study Groups:
This trial has the following groups:- Group 1: SBRT to the breast then surgery
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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