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Stereotactic Body Radiotherapy for Early Stage Breast Cancer

N/A
Waitlist Available
Led By D. Hunter Boggs, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be clinically node negative by physical examination. Sentinel node dissection is not required, but if undertaken, the patient must be pathologically node negative
Zubrod Performance Status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 years
Awards & highlights

Study Summary

This trial offers a new, single-fraction radiation treatment for patients with early stage breast cancer.

Who is the study for?
This trial is for women over 50 with early stage breast cancer who've had a lumpectomy. They must have ER-positive tumors smaller than 2cm (or 2.5cm if it's DCIS), no cancer in the lymph nodes, and be generally healthy. Women can't join if they have invasive lobular cancer, unclear lumpectomy margins on scans, received chemo before surgery, or have multifocal/multicentric cancer.Check my eligibility
What is being tested?
The study tests a targeted radiation therapy called Stereotactic Body Radiation Therapy (SBRT) given in 1-3 sessions after lumpectomy for breast conservation. It aims to see how well this approach works as an alternative to traditional radiation treatments.See study design
What are the potential side effects?
Potential side effects of SBRT may include skin redness, swelling, tenderness at the treatment site, fatigue, and rare risks like rib fractures or secondary cancers due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymph nodes are cancer-free based on physical exams or tests.
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I can take care of myself and am up more than 50% of my waking hours.
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I am over 50 years old.
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My tumor is smaller than 2.0cm if it's invasive, or under 2.5cm if it's only in the milk ducts.
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My cancer is mostly driven by estrogen.
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My breast cancer is confirmed and falls under specific types like IDC or DCIS.
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I am eligible for and will have a lumpectomy with safe margins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity levels of 5 fractions SBRT for partial breast irradiation assessed by CTCAE v4.0
Secondary outcome measures
Cosmetic outcome baseline and post-SBRT
Patient reported outcome baseline and post-SBRT
Toxicity of breast SBRT using CTCAE v4.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: 5 Fraction Breast Stereotactic Body Radiation TherapyExperimental Treatment1 Intervention
This study will enroll patients that have a confirmed histology of early stage breast cancer. The patient will undergo a lumpectomy and will then receive partial breast 5 fractions stereotactic body radiation therapy at a dose of 6 gy for 5 fractions for treatment. Patients will be followed for 36 total months with specific follow-ups at 3, 6, 9, 12, 18, 24, and 36 months.

Find a Location

Who is running the clinical trial?

Varian Medical SystemsIndustry Sponsor
60 Previous Clinical Trials
3,744 Total Patients Enrolled
2 Trials studying Breast Cancer
322 Patients Enrolled for Breast Cancer
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,282,439 Total Patients Enrolled
31 Trials studying Breast Cancer
4,451 Patients Enrolled for Breast Cancer
D. Hunter Boggs, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

5 Fraction Breast Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03643861 — N/A
Breast Cancer Research Study Groups: 5 Fraction Breast Stereotactic Body Radiation Therapy
Breast Cancer Clinical Trial 2023: 5 Fraction Breast Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03643861 — N/A
5 Fraction Breast Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03643861 — N/A
~13 spots leftby Dec 2026
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