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Stereotactic Body Radiotherapy for Early Stage Breast Cancer

N/A

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-2 years

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,314 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

Frequently Asked Questions

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

How many participants can be accepted into this research endeavor?

"Affirmative, the data on clinicaltrials.gov indicates this trial is actively searching for participants and was posted on August 20th 2019 with a last update of November 7th 2022. The study requires 40 individuals who will be recruited from 1 medical institution."

Answered by AI

Do I meet the requirements to partake in this research?

"This research is recruiting 40 individuals affected by breast cancer who are aged 18-99. Participants must meet the following criteria: biopsy confirmed invasive mammary carcinoma, ductal carcinoma in situ (DCIS) of the breast; medullary, papillary, mucinous (colloid), and tubular histologies allowed; over 50 years old; maximal pathologic tumor size less than 2.0 cm for invasive tumours or less than 2.5 cm for pure DCIS cases; estrogen receptor positivity (>10%); be eligible for conservative therapy with lumpectomy exhibiting a minimum margin width of two millimetres; clinically"

Answered by AI

Is the age prerequisite for this clinical trial restricted to those over 20 years old?

"In order to participate in this clinical study, individuals must be aged 18-99. There are also 74 trials for minors and 2507 studies targeting those over the age of 65."

Answered by AI

Is the enrollment period for this research still in progress?

"As indicated on clinicaltrials.gov, this trial is in the process of recruiting participants and was first posted on August 20th 2019 with its most recent revision made on November 7th 2022."

Answered by AI

Recent research and studies

Frontiers in OncologyJournal

Feasibility and Short-term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-stage Breast Cancer Patients Receiving Partial Breast Irradiation

Liu, Yilan, Christopher Veale, Diana Hablitz, Helen Krontiras, Allison Dalton, Korie Meyers, Michael Dobelbower, et al.. 2022. “Feasibility and Short-term Toxicity of a Consecutively Delivered Five Fraction Stereotactic Body Radiation Therapy Regimen in Early-stage Breast Cancer Patients Receiving Partial Breast Irradiation”. Frontiers in Oncology. Frontiers Media SA. doi:10.3389/fonc.2022.901312.

clinicaltrials.govStudy

RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

Drexell Hunter Boggs 2019. "RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03643861.