Stereotactic Body Radiotherapy for Early Stage Breast Cancer

Overseen By Kristin Webb, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Multifocal cancer, Neoadjuvant chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.

Research Team

D. Hunter Boggs, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

My lymph nodes are cancer-free based on physical exams or tests.

I can take care of myself and am up more than 50% of my waking hours.

I am over 50 years old.

Exclusion Criteria

My cancer is present in multiple locations within the same organ.

I have received chemotherapy before surgery.

My breast cancer is of the invasive lobular type.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 fractions of stereotactic body radiotherapy for early stage breast cancer after lumpectomy

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Follow-up appointments at 3, 6, 9, 12, 18, 24, and 36 months

Treatment Details

Interventions

• 1-3 Fraction Stereotactic Body Radiation Therapy
• 5 Fraction Stereotactic Body Radiation Therapy
• Single Fraction Stereotactic Body Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: 5 Fraction Breast Stereotactic Body Radiation Therapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester