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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation therapy to individuals with early-stage breast cancer who have undergone a lumpectomy (surgery to remove the tumor). The study tests different schedules for delivering targeted radiation, known as Stereotactic Body Radiotherapy, to a small part of the breast to determine its effectiveness in preventing cancer recurrence. Eligible participants should have had a lumpectomy and possess a type of breast cancer that is small and does not involve the lymph nodes (small glands that are part of the immune system).

As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that stereotactic body radiotherapy is safe for early stage breast cancer?

Research has shown that 5 Fraction Stereotactic Body Radiation Therapy (SBRT) is safe for individuals with early-stage breast cancer. Studies have found that patients experience few side effects with this treatment. In one study, patients noticed better cosmetic results within the first year after surgery and radiation. Another study confirmed the safety and practicality of this treatment, with no serious side effects reported. While more research is needed to understand long-term effects, current evidence suggests that this treatment is well-tolerated in the short term. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about stereotactic body radiotherapy (SBRT) for early-stage breast cancer because it offers a potentially quicker and more precise treatment option compared to traditional radiation therapy. Unlike standard treatments that often require multiple weeks of daily sessions, SBRT can deliver high doses of radiation in just 1 to 5 sessions. This method targets the tumor with pinpoint accuracy, minimizing damage to surrounding healthy tissue and potentially reducing side effects. By shortening the treatment time and focusing radiation more precisely, SBRT could improve patient convenience and quality of life while maintaining effectiveness.

What evidence suggests that this trial's treatments could be effective for early stage breast cancer?

Research has shown that stereotactic body radiation therapy (SBRT) works well for early-stage breast cancer. In this trial, participants will receive a 5-session SBRT treatment, which earlier studies found to result in good cosmetic outcomes within the first year. This treatment also has few side effects, making it a promising choice for patients. SBRT is precise, targeting only the cancer and sparing nearby healthy tissue. It delivers radiation in just a few sessions, offering convenience and saving time. Overall, early evidence supports the effectiveness of this treatment for patients after a lumpectomy. ^{2 4 5 6 7}

Who Is on the Research Team?

D. Hunter Boggs, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0360301617300287

Preliminary Results of a Phase 1 Dose-Escalation Trial for ... Patients felt cosmetic results improved within the first year after surgery and stereotactic body radiation therapy. Our results show minimal toxicity with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28586960/

Preliminary Results of a Phase 1 Dose-Escalation Trial for ... Patients felt cosmetic results improved within the first year after surgery and stereotactic body radiation therapy. Our results show minimal ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.901312/full

Feasibility and Short-Term Toxicity of a Consecutively ... Stereotactic body radiotherapy (SBRT) is a promising technique to deliver APBI because of its increased accuracy and sparing of uninvolved ...

4. redjournal.org redjournal.org/article/S0360-3016(15)00876-7/pdf

Stereotactic Body Radiation Therapy for Early-Stage Breast ... to allow the breast to remain in its natural position. All patients received a dose of 3,000 cGy in 5 fractions of 600 cGy each given on five consecutive days.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04985032

Accelerated Partial Breast Irradiation (APBI) Using ... Cosmetic Outcomes of a Phase 1 Dose Escalation Study of 5-Fraction Stereotactic Partial Breast Irradiation for Early Stage Breast Cancer. Int J Radiat Oncol ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35880164/

Feasibility and Short-Term Toxicity of a Consecutively ... Conclusions: Although longer follow-up is needed to assess long-term toxicity and local control, this study demonstrated a five-fraction SBRT ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03643861

RAD 1802: Pilot Trial of Five Fraction Stereotactic Body ... This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.