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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Trial 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
558 Previous Clinical Trials
32,880 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

SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03043794 — Phase 2
Breast Cancer Research Study Groups: SBRT to the breast then surgery
Breast Cancer Clinical Trial 2023: SBRT Highlights & Side Effects. Trial Name: NCT03043794 — Phase 2
SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043794 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an enrollment period open for this clinical trial at present?

"Yes, this research is still open for participation. Clinicaltrials.gov indicates that the project was initially published on August 1st 2017 and revised most recently on October 25th 2022."

Answered by AI

How many participants are currently included in this clinical trial?

"Affirmative, the data hosted on clinicaltrials.gov indicates that recruitment for this medical trial is underway. It was first posted to the website on August 1st 2017 and last modified October 25th 2022; 40 individuals are sought from two separate sites."

Answered by AI

Are there any regulatory approvals for the utilization of Stereotactic Body Radiation SBRT?

"The safety of Stereotactic Body Radiation SBRT was rated a 2 due to the Phase 2 nature of this trial, indicating that while there may be some data supporting its security no studies have evaluated its efficacy."

Answered by AI

Who is eligible to partake in this research endeavor?

"This study is currently recruiting 40 individuals diagnosed with breast cancer of ages between 50 and 100. In order to be considered, these patients must meet the following conditions: Age ≥ 50 years old; Invasive ductal carcinoma; Clinically and radiographically T1 tumor Clinically node negative; Clearly demarcated tumour detected by MRI (which may occur after enrolment); Planning for a sentinel lymph node biopsy as part of a breast conserving surgery; Express at least 10% ER/PR receptors, HER2 status in accordance with College of American Pathologists guidelines; Post-menopausal state or equivalent hormone replacement therapy regime if"

Answered by AI

Is eligibility for this research restricted to individuals below a certain age threshold?

"In line with the qualifications for joining this clinical trial, participants must be between 50 and 100 years old."

Answered by AI
~3 spots leftby Dec 2024