Hypofractionated Radiation Therapy for Breast Cancer

Overseen By Mindi J TenNapel, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Inflammatory breast cancer, Metastatic, Scleroderma, Lupus, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a shorter course of radiation therapy, known as hypofractionated radiation, results in different rates of lymphedema (swelling due to fluid build-up) in breast cancer patients compared to the conventional, longer course. The trial focuses on patients requiring additional radiation to lymph nodes after surgery and chemotherapy. It seeks participants with stage II or III node-positive breast cancer or a specific type of stage III node-negative breast cancer who have not previously received radiation in the treatment area.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that may 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 hypofractionated radiation therapy is safe for breast cancer patients?

Research has shown that hypofractionated radiation therapy is generally safe for treating breast cancer. One study found low rates of immediate side effects, with most patients not experiencing serious issues right after treatment. Another study revealed that more than half of the patients did not develop skin problems, such as redness or irritation, which are common concerns with radiation.

Additionally, long-term results suggest that this therapy carries a low risk of side effects overall. This indicates that it is not only effective but also well-tolerated by patients. While individual reactions may vary, these findings suggest that hypofractionated radiation therapy is a safe option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for breast cancer involve traditional radiation therapy, which typically requires daily sessions over five to seven weeks. Hypofractionated Radiation Therapy is unique because it delivers higher doses of radiation over a shorter period, specifically four weeks, without compromising effectiveness. Researchers are excited about this method because it can reduce the overall treatment time, making it more convenient for patients while potentially minimizing the side effects associated with prolonged radiation exposure. This approach not only aims to maintain the efficacy of standard treatments but also enhances patient comfort and adherence by shortening treatment duration.

What evidence suggests that hypofractionated radiation therapy is effective for breast cancer?

Research has shown that hypofractionated radiation therapy, which uses fewer but larger doses of radiation over a shorter period, effectively treats breast cancer. In one study, 69.8% of women who received this type of radiation had good or excellent cosmetic results after 10 years, similar to those who had regular radiation. Another study found that hypofractionated radiation resulted in low rates of immediate side effects. Overall, this treatment appears to work as well as the traditional method but requires less time to complete. This can be particularly beneficial for those who wish to reduce their time in treatment. Participants in this trial will receive hypofractionated radiation therapy daily for 4 weeks. ^{1 3 5 6 7}

Who Is on the Research Team?

Shane Stecklein, MD, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for women with certain stages of breast cancer who may be of child-bearing age and agree to use contraception. They should have had prior surgery or chemotherapy but no radiation in the target area, and their physical condition must allow them to participate actively in daily life.

Inclusion Criteria

I have a specific type of cancer with certain high-risk features.

I agree to use effective birth control or abstain from sex during and for 90 days after the study.

I can perform most of my daily activities without assistance.

Exclusion Criteria

I have been cancer-free for over 5 years, except for skin cancer.

I have been diagnosed with lupus.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hypofractionated radiation therapy daily for 4 weeks

4 weeks

Follow-up

Participants are monitored for lymphedema rates, cosmetic outcomes, local recurrence, quality of life, and range of motion

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study is testing hypofractionated radiation therapy compared to conventional radiation, specifically looking at lymphedema rates (swelling due to fluid build-up) among patients needing regional nodal irradiation.

How Is the Trial Designed?

Group I: Hypofractionated Radiation Therapy Experimental Treatment 1 Intervention

Daily for 4 weeks

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

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

In a study of 463 breast cancer patients, hypofractionated radiotherapy (HFRT) showed a similar rate of locoregional recurrence compared to conventional fractionated radiotherapy (CFRT), with 2.7% recurrence in HFRT versus 4.3% in CFRT.

The 4-year local recurrence-free survival rates were also comparable, with 97% for HFRT and 95% for CFRT, indicating that HFRT is a safe and effective alternative for treating locally advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative retrospective analysis of locoregional recurrence in unselected breast cancer patients treated with conventional versus hypofractionated radiotherapy at a tertiary cancer center? Yadav, R., Lal, P., Agarwal, S., et al.[2022]

In a study of 1,010 breast cancer patients, hypofractionated radiotherapy (HFRT) showed similar locoregional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates compared to conventionally fractionated radiotherapy (CFRT) after a median follow-up of 49.5 months.

While HFRT was effective across various nodal stages and molecular subtypes, it tended to show lower DFS in N2-3 patients with triple-negative breast cancer compared to CFRT, indicating a need for further investigation in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. Chen, F., Hui, TSK., Ma, L., et al.[2022]

Hypofractionated radiotherapy is gaining importance in breast cancer treatment, suggesting a shift towards more efficient radiation delivery methods.

The introduction of simultaneous integrated boost techniques allows for targeted treatment of the primary tumor region, potentially improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. Nitsche, M., Dunst, J., Carl, UM., et al.[2020]

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]

In a study of 56 breast cancer patients receiving hypofractionated external beam radiotherapy (HFRT) after mastectomy, the treatment was well tolerated with mild to moderate acute skin toxicity, and no severe hematological toxicity was observed, indicating a favorable safety profile.

HFRT effectively delivered targeted doses to the chest wall while minimizing exposure to surrounding organs, with mean lung and heart doses remaining within safe limits, suggesting that HFRT can be a viable option for post-mastectomy radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. Deshmukh, S., Sharan, K., Fernandes, DJ., et al.[2022]

In a study of 81 patients with localized breast cancer treated with hypofractionated radiotherapy (HFRT), the treatment was well-tolerated, with low rates of late toxicities such as chest pain (11%) and limb pain (12%).

The five-year overall survival rate was 76.5%, and there were no locoregional recurrences, indicating that HFRT is effective in controlling the disease while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. Sindhu, M., Malik, M., Ahmed, SF., et al.[2022]

In a study of 274 early breast cancer patients treated with hypofractionated radiation treatment (HFRT) over a median follow-up of 7 years, the local recurrence-free survival rate was very high at 97.2%, indicating that HFRT is effective in preventing local cancer recurrence.

The acute toxicity associated with HFRT was generally low, with most patients experiencing less than grade 3 side effects, suggesting that HFRT is a safe treatment option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. James, ML., Dehn, G., Robinson, BA.[2018]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845660/

Efficacy and safety analysis of hypofractionated and ... In this meta-analysis, we conducted a comparative analysis of the safety and efficacy of hypofractionated and conventional fractionated ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006526

Once-Weekly Ultra-Hypofractionated Radiation Therapy for ... This study reports outcomes of once-weekly adjuvant whole-breast radiotherapy in elderly and/or comorbid patients with breast cancer, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3346174/

Are Three Weeks of Whole-Breast Radiotherapy as Good ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

5. 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.

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

Real World Safety of Adjuvant Ultra Hypofractionated ... Ultra-hypofractionated breast radiotherapy (26 Gy in 5 fractions) was well tolerated. · More than half of patients showed no skin toxicity; grade ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34670727/

Hypofractionated Radiation Therapy (HFRT) of Breast ... Conclusion: Given the excellent local control, survival rates and the low toxicity profile demonstrated, HFRT could be considered a valid therapeutic option in ...