Balloon Brachytherapy and External Beam Irradiation for Breast Cancer

(APBI Trial)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sentara Norfolk General Hospital

Must not be taking: Raloxifene, Tamoxifen, SERMs

Disqualifiers: Stage II-IV cancer, Multicentric carcinoma, Paget's disease, Collagen vascular disease, others

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

Compensation: Varies

Number of Visits: 10

Duration: 1-2 weeks

139 Participants Needed

Trial Summary

What is the purpose of this trial?

Breast cancer patients at Sentara RMH Hahn Cancer Center who are treated with accelerated partial breast irradiation will be monitored over a period of 10 years. From this group of patients, local and regional recurrence rates will be determined. Patients in the registry will also take part in assessments of cosmesis and quality of life.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormonal therapy, it must stop at or before study entry and can resume after chemotherapy if applicable. Also, any current therapy with hormonal agents like raloxifene or tamoxifen must be discontinued before joining the study.

What data supports the effectiveness of the treatment Balloon Brachytherapy and External Beam Irradiation for Breast Cancer?

Research shows that balloon-based brachytherapy, a part of this treatment, is effective for early-stage breast cancer by delivering targeted radiation in a short time, reducing exposure to healthy tissues. Studies have demonstrated positive outcomes with this method, making it a promising option for breast cancer therapy. ^{1 2 3 4 5}

Is balloon brachytherapy safe for humans?

Balloon brachytherapy for breast cancer has been studied for safety, with some concerns about skin, chest wall, and lung exposure leading to potential side effects. Safety practices and quality assurance are important to minimize risks, and surveys have been conducted to improve safety in brachytherapy treatments. ^{1 6 7 8 9}

How is balloon brachytherapy different from other breast cancer treatments?

Balloon brachytherapy is unique because it delivers radiation directly to the area around the lumpectomy cavity, reducing treatment time from about 6 weeks to just 5 days, and minimizing exposure to surrounding healthy tissues like the skin and chest wall. ^{1 2 6 10 11}

Research Team

Heather A. Morgan, MD

Principal Investigator

Sentara RMH Medical Center

Eligibility Criteria

This trial is for women over 50 or postmenopausal with stage 0 or 1 breast cancer, having a single tumor ≤2-3 cm based on type. They must have had a lumpectomy with clear margins and no prior treatments for the current cancer except limited hormonal therapy. Men, pregnant/lactating women, those with certain previous cancers or conditions like collagen vascular disease are excluded.

Inclusion Criteria

My breast cancer is either DCIS or invasive but not lobular.

The area removed by my breast surgery is less than 25% of my whole breast.

I had a lumpectomy with clear margins of 2 mm or more.

Exclusion Criteria

You have mental health or addiction issues that could prevent you from participating in the study.

I may have had hormone therapy for my current breast cancer, but only for up to 28 days.

My breast cancer is found in multiple areas or is spread out.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive partial breast irradiation using 3D conformal external beam irradiation or balloon brachytherapy

1-2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

10 years

Yearly visits (in-person)

Treatment Details

Interventions

• 3D Conformal External Beam Irradiation
• Balloon Brachytherapy

Trial Overview The study at Sentara RMH Hahn Cancer Center monitors patients treated with accelerated partial breast irradiation (APBI) over ten years to observe recurrence rates and assess cosmesis and quality of life. APBI will be delivered either by external beam radiation or balloon brachytherapy.

Participant Groups

Group I: Partial Breast Irradiation Experimental Treatment 2 Interventions

All participants will be treated with partial breast irradiation by utilizing 3D conformal external beam irradiation or balloon brachytherapy. This is not a randomized study.

Who Is Running the Clinical Trial?

Sentara Norfolk General Hospital

Lead Sponsor

Trials

12

Recruited

890+

References

1. United States pubmed.ncbi.nlm.nih.gov

Four-year results using balloon-based brachytherapy to deliver accelerated partial breast irradiation with a 2-day dose fractionation schedule. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the MammoSite breast brachytherapy applicator in women with early-stage breast cancer treated with breast-conserving therapy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Xoft Axxent electronic brachytherapy. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I/II study evaluating early tolerance in breast cancer patients undergoing accelerated partial breast irradiation treated with the mammosite balloon breast brachytherapy catheter using a 2-day dose schedule. [2010]

6. Iran pubmed.ncbi.nlm.nih.gov

A Comparison of Skin Dose Delivered with MammoSite and Multicatheter Breast Brachytherapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety practices and opportunities for improvement in brachytherapy: A patient safety practices survey of the American Brachytherapy Society membership. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

The incidence of fat necrosis in balloon-based breast brachytherapy. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Brachytherapy patient safety events in an academic radiation medicine program. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of conservative management techniques in the re-treatment of ipsilateral breast tumor recurrence. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Early outcomes data for accelerated partial breast irradiation using balloon brachytherapy. [2011]