Ultra-Hypofractionated vs. Hypofractionated Radiation for Breast Cancer

(SWIFT RT Trial)

Recruiting at 1 trial location

Overseen By Maria Thomas, M.D., Ph.D.

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Distant metastases, Bilateral breast cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-4 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiation therapy to determine which is more effective for breast cancer patients with cancer in their lymph nodes. Ultra-hypofractionated radiation uses a few larger doses over a short period, while hypofractionated radiation uses smaller doses over a longer time. The researchers aim to assess whether the shorter treatment is as safe and effective, while also examining side effects and quality of life. Women who have undergone breast cancer surgery, have specific types of breast cancer, and have cancer in their lymph nodes may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during radiation treatment, so you may be able to continue these if applicable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ultra-hypofractionated radiation therapy is generally well-tolerated by breast cancer patients. In one study, more than half of the patients did not experience skin problems. Immediate side effects were rare, and changes in appearance were minimal. Another study found that long-term side effects after one year remained at acceptable levels.

Hypofractionated radiation therapy, on the other hand, is already a common treatment. It has proven to be as safe and effective as traditional radiation schedules. Studies comparing both treatments have found that ultra-hypofractionated radiation is just as safe as hypofractionated radiation in certain situations.

In summary, while researchers continue to study ultra-hypofractionated radiation therapy, early findings suggest it is well-tolerated with low rates of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ultra-hypofractionated radiation for breast cancer because it offers a potentially faster and more convenient treatment option compared to traditional hypofractionated radiation. Unlike the standard treatment that typically takes 3-4 weeks, ultra-hypofractionated radiation delivers a higher dose in just 5 sessions over 1-2 weeks. This approach could reduce the burden of treatment for patients, possibly leading to improved quality of life while maintaining effectiveness. Additionally, by shortening the treatment duration, this method might increase access to care and reduce healthcare costs.

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

This trial will compare hypofractionated radiation therapy with ultra-hypofractionated radiation therapy for breast cancer. Studies have shown that hypofractionated radiation therapy controls breast cancer as effectively as the traditional method and maintains a similarly low rate of side effects. Patients who received this treatment had excellent survival rates and very few serious side effects. Research on ultra-hypofractionated radiation, which participants in this trial may receive, suggests it also effectively reduces the risk of cancer returning, with low rates of skin and cosmetic issues. This newer approach requires fewer sessions, potentially offering more convenience for patients. Overall, both treatments appear promising in managing breast cancer with minimal harm. ^{2 3 6 7 8}

Who Is on the Research Team?

Maria Thomas, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for breast cancer patients with lymph node involvement who have undergone surgery. Participants should be suitable for radiation therapy and willing to undergo different radiation schedules. Those with prior radiation in the treatment area or conditions that could interfere with radiotherapy are excluded.

Inclusion Criteria

My cancer has spread to the lymph nodes in my armpit, confirmed by a biopsy.

I had surgery to remove lymph nodes in my armpit.

Able to understand and willing to sign IRB-approved written informed consent document.

Exclusion Criteria

Pregnancy, which will be excluded prior to simulation.

I have been diagnosed with cancer in both breasts.

I have a health condition that may limit my life to less than 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ultra-hypofractionated or hypofractionated breast/chest wall and regional nodal radiation

1-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of acute and late toxicity, oncologic outcomes, and quality of life

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated radiation
• Ultra-hypofractionated breast/chest wall and regional nodal radiation

Trial Overview The study compares two types of post-surgery radiation treatments: standard hypofractionated (shorter, higher-dose sessions over 3 weeks) versus ultra-hypofractionated (even shorter, more intense doses over 1 week), focusing on their effectiveness and safety when treating both the breast/chest wall and regional nodes.

How Is the Trial Designed?

Group I: Ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) Experimental Treatment 1 Intervention

Breast/chest wall and nodal radiation (2600 cGy in 5 fractions over 1-2 weeks).

Group II: Hypofractionated radiation (RT) Active Control 1 Intervention

Breast/chest wall and nodal radiation (4256 cGy in 16 fractions over 3-4 weeks).

Hypofractionated radiation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hypofractionation for:

• Breast cancer
• Node-positive breast cancer

Approved in United States as Hypofractionation for:

• Breast cancer
• Node-positive breast cancer

Approved in Canada as Hypofractionation for:

• Breast cancer
• Node-positive breast cancer

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a study involving 396 patients treated with ultra-hypofractionated breast radiotherapy, the five-year local-relapse free survival (LRFS) rate was an impressive 98.8%, indicating high efficacy in controlling breast cancer.

While ultra-hypofractionated radiotherapy showed excellent tumor control, certain regimens, particularly the 5.7 Gy weekly fraction and tumor bed boost, were linked to a higher risk of acute and late skin toxicities, highlighting the need for careful treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large scale experience of two ultrahypofractionated 5 fractions regimes after breast conserving surgery from a single centre. Sauvage, LM., Loap, P., Vu-Bezin, J., et al.[2023]

Hypofractionated radiation therapy, which delivers fewer but larger doses of radiation over a shorter period, has shown comparable outcomes to conventional radiation in treating breast cancer, suggesting it could be an effective alternative.

Ongoing phase 3 trials are investigating hypofractionated whole breast irradiation and accelerated partial breast irradiation, which may lead to broader acceptance of these methods for early-stage breast cancer, although concerns about patient selection and late toxicity remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Freedman, GM.[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 393 breast cancer patients treated with moderately hypofractionated radiotherapy (HYPO-RT) over a median follow-up of 5.7 years, the overall survival rates were high at 96.0% at 5 years and 79.3% at 10 years, indicating the efficacy of this treatment.

HYPO-RT demonstrated excellent local control with only 4.3% local recurrences and low toxicity rates, with severe acute dermatitis occurring in just 0.9% of patients, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in breast cancer: a 10-year single institution experience. Najas, GF., Stuart, SR., Marta, GN., et al.[2022]

Hypofractionated radiotherapy is gaining popularity for breast cancer treatment in the UK and Canada, but there are concerns about potential increased toxicity associated with this approach.

The article emphasizes the importance of careful planning and dosimetry in hypofractionated radiotherapy to ensure effective treatment while minimizing risks, and it provides recommendations for both planning and monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? MacLeod, N., McIntyre, A., Canney, PA.[2018]

Hypofractionated radiation therapy (HypoRT) for breast cancer, which delivers higher doses per fraction (2.5-3.0 Gy), has shown favorable outcomes in clinical trials, suggesting it can be an effective alternative to conventional radiation therapy.

The review highlights that despite some concerns among radiation oncologists, the evidence from high-quality randomized trials supports the safety and efficacy of HypoRT, making it a timely option for treatment, especially during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Journey to hypofractionation in radiotherapy for breast cancer: critical reviews for recent updates. Kim, N., Kim, YB.[2023]

Hypofractionated radiation therapy (HypoRT) was found to be effective in treating inoperable advanced non-small cell lung cancer (NSCLC), with an overall response rate of 83% among 30 patients, and a median follow-up of 13 months.

The treatment was well-tolerated, with manageable acute toxicities; however, 37% of patients experienced locoregional recurrence, and 57% developed distant metastasis, indicating the need for further studies to compare HypoRT with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. Osti, MF., Agolli, L., Valeriani, M., et al.[2018]

In a study of 257 breast cancer patients treated with hypofractionated radiation therapy (HFRT), the 5-year overall survival rate was 86.6%, indicating that HFRT is effective for patients with breast cancer and nodal involvement.

The treatment was associated with manageable side effects, with no serious complications like cardiac issues or pneumonitis reported, although some patients experienced mild to moderate skin changes and lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Regional Nodal Irradiation for Women With Node-Positive Breast Cancer. Bellefqih, S., Elmajjaoui, S., Aarab, J., et al.[2022]

Hypofractionated radiation therapy (HFRT) for locally advanced breast cancer showed excellent overall survival rates of 100% at 1 year and 90% at 3 years, indicating its efficacy as a treatment option.

The treatment had a low toxicity profile, with only 1.6% of patients experiencing local recurrence and manageable rates of skin toxicity and lymphedema, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiation Therapy (HFRT) of Breast/Chest Wall and Regional Nodes in Locally Advanced Breast Cancer: Toxicity Profile and Survival Outcomes in Retrospective Monoistitutional Study. De Matteis, S., Facondo, G., Valeriani, M., et al.[2022]

Citations

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an open-label randomized controlled study (HYPORT-Adjuvant) A meta-analysis of these trials has shown that hypofractionated radiotherapy is similar to conventionally fractionated radiotherapy in terms of locoregional ...

2. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(21)00266-4/fulltext

Hypofractionated Radiation Therapy (HFRT) of ... HFRT showed excellent survival outcomes comparable to conventional fractionation. HFRT had excellent toxicity profile, with no acute nor late toxicities ≥G3.

3. ascopubs.org ascopubs.org/doi/10.1200/GO-24-00277

Phase II Evaluation of Ultra-Hypofractionated ... The study found that ultra-hypofractionated radiation therapy in patients with breast cancer had low rates of acute toxicity and cosmesis changes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002344

Real World Safety of Adjuvant Ultra Hypofractionated ... Adjuvant radiotherapy (RT) improves local control and progression-free survival rates after conservative or radical surgery in breast cancer.2,3 ...

5. thelancet.com thelancet.com/journals/lansea/article/PIIS2772-3682(24)00042-8/fulltext

Preliminary results of hypofractionated radiotherapy in ... We found that the two radiation schedules were comparable in terms of acute skin toxicity. Cosmetic outcome was better in the 2-week schedule.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12364632/

Impact on outcomes of ultra hypofractionation or ... Overall, it reduced the risk of recurrence by 16% at 10 years and breast cancer-specific survival by 4% at 15 years. Different groups exhibit ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/528440

Ultra-Hypofractionated vs. Hypofractionated Radiation for ... Ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated ...

8. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00231-8/fulltext

Ultrahypofractionated Adjuvant Breast Radiation Therapy ... Ultrahypofractionated breast radiation therapy leads to acceptable late toxicity at 1 year, even when followed by a hypofractionated tumor bed ...