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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of balloon brachytherapy, a type of internal radiation therapy, for individuals with early-stage breast cancer. The researchers aim to determine the frequency of cancer recurrence and assess the treatment's impact on appearance and daily life over ten years. Participants will receive radiation that targets only part of the breast, with their health closely monitored. Women who have undergone a lumpectomy for stage 0 or 1 breast cancer, with tumors no larger than 2-3 cm and no previous major breast cancer treatments, may be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could shape future breast cancer treatments.

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 prior data suggests that balloon brachytherapy and 3D conformal external beam irradiation are safe for breast cancer treatment?

Research has shown that balloon brachytherapy is generally safe, though it carries some risks. One study found that about 20.4% of women undergoing this treatment experienced wound healing problems. In contrast, 12.7% of women receiving whole breast irradiation (WBI) faced similar issues.

For 3D conformal external beam irradiation, studies have shown encouraging results. Research found that patients experienced fewer short-term side effects and better cosmetic outcomes compared to WBI. Specifically, they had fewer noticeable changes in breast appearance and felt less discomfort during treatment.

Overall, both treatments are generally well-tolerated, with manageable side effects. Discussing these risks with a doctor is important to understand their implications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Balloon brachytherapy is unique because it offers a more targeted form of radiation treatment for breast cancer. Unlike traditional radiation therapy, which can affect a larger area, balloon brachytherapy focuses the radiation precisely on the area where cancer was removed. This method has the potential to minimize exposure to healthy tissues and reduce side effects. Researchers are excited about this treatment because it may allow for a shorter treatment duration and could improve the quality of life for patients by reducing the overall burden of therapy.

What evidence suggests that balloon brachytherapy and 3D conformal external beam irradiation could be effective for breast cancer?

Research has shown that balloon brachytherapy, such as the MammoSite device, effectively treats early-stage breast cancer. Studies indicate that it delivers radiation directly to the tumor area, providing excellent local control. Five-year results suggest high survival rates, with breast cancer-specific survival nearly 100%. In this trial, participants will receive partial breast irradiation using either balloon brachytherapy or 3D conformal external beam irradiation. Evidence shows that 3D conformal external beam irradiation effectively reduces the chance of cancer returning in the treated area. Both treatments generally result in good cosmetic outcomes, preserving the breast's appearance. ^{5 6 7 8 9}

Who Is on the Research Team?

Heather A. Morgan, MD

Principal Investigator

Sentara RMH Medical Center

Are You a Good Fit for This Trial?

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.

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3365530/

INITIAL EFFICACY RESULTS OF RTOG 0319: THREE ... Interim results of a phase I/II trial of 3D-conformal external beam accelerated partial breast irradiation in patients with early breast cancer. Int J ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7648201/

Accelerated partial breast irradiation with 3-dimensional ... To present the 7-year results of accelerated partial breast irradiation (APBI) using three-dimensional conformal (3D-CRT) and image-guided ...

3. redjournal.org redjournal.org/article/S0360-3016(21)02871-6/fulltext

Comparative Effectiveness Analysis of 3D-Conformal ... Of 1185 patients treated with 3DCRT and conventional fractionation, 650 (54.9%) experienced acute toxicity; of 774 treated with highly segmented ...

4. nature.com nature.com/articles/s41598-024-73627-x

A systematic review on the techniques, long-term outcomes ... Nowadays, a large number of studies have shown that 3DCRT, as one of the treatment methods for PBI, has no difference in local recurrence, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301607007596

Interim Cosmetic Results and Toxicity Using 3D Conformal ... Delivery of APBI with 3D-CRT resulted in minimal chronic (≥6 months) toxicity to date with good/excellent cosmetic results. Additional follow-up is needed to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24161420/

Five-year outcomes, cosmesis, and toxicity with 3- ... APBI delivered by 3D-CRT to the tumor bed for a selected group of early-stage breast cancer patients produces 5-year results similar to those achieved with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0960740425001203

Ten-Year Outcomes of 3D-Conformal Accelerated Partial ... In this study we compared clinical outcomes after accelerated partial breast irradiation (APBI) versus whole breast irradiation (WBI) using 3- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7136642/

Comparison of Toxicity and Cosmetic Outcomes After ... In women with breast cancer after BCS, APBI was associated with better cosmetic outcome and fewer acute and late radiation toxicities than WBI.

9. redjournal.org redjournal.org/article/S0360-3016(13)03081-2/abstract

Five-Year Outcomes, Cosmesis, and Toxicity With 3- ... APBI delivered by 3D-CRT to the tumor bed for a selected group of early-stage breast cancer patients produces 5-year results similar to those achieved with ...