Accelerated Radiation Therapy for Breast Cancer

(ASHBY Trial)

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

Must be taking: Her2 therapy, Aromatase inhibitors

Disqualifiers: Pregnant, Collagen-vascular disease, Paget's, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your tumor is HER2-positive, you must continue with HER2-directed therapy.

What data supports the effectiveness of the treatment Accelerated Super-Hypofractionated Breast Brachytherapy (ASHBY) for breast cancer?

Research shows that accelerated hypofractionated radiotherapy, which is similar to ASHBY, is effective for early breast cancer, offering a shorter treatment time with good tolerance and efficacy. This approach involves delivering higher doses of radiation in fewer sessions, which has been shown to be effective in treating breast cancer after surgery. ^{1 2 3 4 5}

Is accelerated radiation therapy for breast cancer safe?

Research shows that accelerated radiation therapy, including various hypofractionated schedules, is generally safe for breast cancer patients. Studies have reported no significant increase in adverse effects compared to traditional schedules, and trials like UK-FAST and FAST-Forward have demonstrated safe toxicity profiles with long-term follow-up. ^{5 6 7 8 9}

How is the Accelerated Super-Hypofractionated Breast Brachytherapy treatment different from other breast cancer treatments?

Accelerated Super-Hypofractionated Breast Brachytherapy (ASHBY) is unique because it delivers a higher dose of radiation in fewer sessions, specifically targeting the part of the breast where the cancer was removed, which can reduce the overall treatment time compared to traditional methods. ^{1 2 3 5 10}

Research Team

Bridget Quinn, MD, Ph.D

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals with breast cancer who are eligible for radiation therapy. Specific eligibility criteria are not provided, but typically participants would need to have a certain stage of cancer and be in good enough health to undergo the treatment.

Inclusion Criteria

I was diagnosed with my condition between the ages of 45 and 79.

If my cancer is HER2-positive, I must get HER2-targeted treatment.

My breast cancer surgery included checking the underarm lymph nodes, which were cancer-free.

Exclusion Criteria

Pregnant or breastfeeding

I have had breast cancer or DCIS before my current diagnosis.

I have an active collagen-vascular disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant over 1.5 days

1.5 days

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

5 years

Baseline, 1 year, 3 years, and 5 years following irradiation

Treatment Details

Interventions

• Accelerated Super-Hypofractionated Breast Brachytherapy

Trial Overview The study is testing accelerated partial breast irradiation, which is a focused type of radiation therapy given over just three treatments in approximately two days, instead of the usual several weeks.

Participant Groups

Group I: Accelerated Partial Breast Irradiation (APBI) Experimental Treatment 1 Intervention

7.5 gray (Gy) × 3 fractions via multicatheter brachytherapy

Accelerated Super-Hypofractionated Breast Brachytherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Accelerated Hypofractionated Breast Brachytherapy for:

• Early-stage breast cancer

Approved in European Union as Accelerated Partial-Breast Irradiation for:

• Early-stage breast cancer
• Stage I or II breast cancer

Approved in Canada as Accelerated Hypofractionated Breast Brachytherapy for:

• Early-stage breast cancer

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

In a study of 98 breast cancer patients treated with accelerated hypofractionated radiotherapy, the treatment showed excellent local control and disease-free survival rates of 100% and 98% respectively after 2 years, indicating high efficacy.

The treatment was well tolerated, with 99% of patients reporting satisfaction with cosmetic outcomes and no significant pain or severe side effects observed, making it a safe option for breast cancer post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for breast cancer acceleration of the START A treatment regime: intermediate tolerance and efficacy. Janssen, S., Glanzmann, C., Lang, S., et al.[2021]

Hypofractionated radiotherapy is increasingly being used as an effective adjuvant treatment for early breast cancer, offering a shorter treatment duration compared to traditional methods.

Accelerated partial breast irradiation techniques are being highlighted for their potential benefits in targeting specific areas of the breast, which may improve patient outcomes and reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Accelerated partial breast irradiation for early breast cancer]. Bourgier, C., Dumas, I., Marsiglia, H., et al.[2018]

Hypofractionated radiation therapy is an effective treatment option for selected early breast cancer patients after breast-conserving surgery, allowing for higher doses in fewer sessions.

The optimal timing, fractionation, and total dose for delivering the tumor bed boost in hypofractionated schedules are still being researched, indicating a need for further studies to refine treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence. Franco, P., Cante, D., Sciacero, P., et al.[2020]

In a study of 27 breast cancer patients, accelerated hypofractionated radiotherapy with simultaneous integrated boost (SIB) showed acceptable rates of acute skin toxicity, with only 33% experiencing grade 1 and 18.5% experiencing grade 2 toxicities, indicating a relatively safe treatment option.

The treatment resulted in good disease-free survival (DFS) and overall survival (OS) rates of 88% and 92% at four years, respectively, with excellent or good cosmetic outcomes in 100% of patients, demonstrating both efficacy and favorable long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated breast radiotherapy with simultaneous integrated boost: a feasibility study. Yadav, BS., Gupta, S., Dahiya, D., et al.[2022]

In a study of 39 breast cancer patients treated with an accelerated hypofractionated radiotherapy schedule, no significant lung toxicity or adverse effects were observed after a median follow-up of 43 months, indicating the treatment's safety.

The radiotherapy regimen (34 Gy in 10 fractions plus an 8 Gy boost) was well-tolerated, with only minor skin changes noted in a few patients, suggesting it is a feasible option for adjuvant treatment without significant long-term side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. Pinnarò, P., Soriani, A., Landoni, V., et al.[2021]

Randomized trials indicate that hypofractionation using 2.67 Gy fractions for adjuvant whole breast radiotherapy does not compromise local tumor control or increase late adverse effects, suggesting it is a safe treatment option.

There is potential for even fewer larger fractions to be safely administered, but ongoing research is needed to determine the effectiveness and safety of a 5-fraction schedule, especially considering the volume of breast tissue treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy. Yarnold, J., Haviland, J.[2018]

In a study of 89 patients treated with hypofractionated radiotherapy for early-stage breast cancer, ultrasound measurements showed that skin thickness increased significantly in both the irradiated breast and boost regions compared to the non-treated breast, indicating potential late skin toxicity.

The study demonstrated that ultrasound can effectively assess late skin toxicity and correlate it with clinical signs of fibrosis, suggesting it could be a reliable tool for monitoring treatment effects in breast cancer radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence from a breast cancer hypofractionated schedule: late skin toxicity assessed by ultrasound. Landoni, V., Giordano, C., Marsella, A., et al.[2021]

In a study of 151 early-stage breast cancer patients treated with accelerated partial-breast irradiation (APBI) using Volumetric Modulated Arc Therapy (VMAT), acute toxicities were generally mild, with only 24.5% experiencing Grade 1 erythema and minimal higher-grade skin toxicities.

The treatment was well-tolerated, with 27.1% of patients reporting Grade 1 fibrosis and only 1.3% experiencing Grade 2 fibrosis, indicating that APBI with VMAT is a feasible and effective option for early breast cancer patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VMAT partial-breast irradiation: acute toxicity of hypofractionated schedules of 30 Gy in five daily fractions. La Rocca, E., Lozza, L., D' Ippolito, E., et al.[2021]

The UK-FAST trial showed that a once weekly hypofractionated radiotherapy regimen (5 fractions of 5.7 Gy) for whole breast irradiation had similar toxicity levels compared to the conventional regimen (50 Gy in 25 fractions) over a 10-year follow-up, indicating it is a safe alternative.

The FAST-Forward trial demonstrated that a 5-fraction regimen (5.2 Gy per fraction) over one week is non-inferior in local control compared to the standard 40 Gy in 15 fractions over three weeks, supporting the efficacy of extreme hypofractionation in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. Bockel, S., Louvel, G., Brion, T., et al.[2021]

In a study of 200 breast cancer patients, those receiving accelerated radiotherapy in 5 fractions experienced significantly lower acute toxicity compared to those receiving treatment in 15 fractions, with notable reductions in breast pain, fatigue, edema, and dermatitis.

Patients treated with the 5-fraction schedule reported better health-related quality of life, including improved physical well-being and less deterioration in social functioning, indicating that this treatment approach may enhance patient comfort and overall experience during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost. Van Hulle, H., Vakaet, V., Monten, C., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for breast cancer acceleration of the START A treatment regime: intermediate tolerance and efficacy. [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Accelerated partial breast irradiation for early breast cancer]. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence. [2020]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated breast radiotherapy with simultaneous integrated boost: a feasibility study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated radiotherapy as adjuvant regimen after conserving surgery for early breast cancer: interim report of toxicity after a minimum follow up of 3 years. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Evidence from a breast cancer hypofractionated schedule: late skin toxicity assessed by ultrasound. [2021]

8. Italy pubmed.ncbi.nlm.nih.gov

VMAT partial-breast irradiation: acute toxicity of hypofractionated schedules of 30 Gy in five daily fractions. [2021]

9. France pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost. [2022]