Hypofractionated Radiation Therapy for Breast Cancer

Not currently recruiting at 881 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Metaplastic breast cancer, T4, N3, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using hypofractionated radiation therapy (a form of radiation treatment) after a mastectomy in patients with certain stages of breast cancer. The researchers aim to determine if higher doses of radiation over a shorter period can prevent cancer recurrence and reduce side effects. Participants are divided into two groups: one receives the new, shorter radiation schedule, and the other follows the standard, longer schedule. This trial may suit those who have undergone a mastectomy for stage IIa-IIIa breast cancer and have not previously received chest radiation therapy. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

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.

Is there any evidence suggesting that hypofractionated radiation therapy is likely to be safe?

Research has shown that hypofractionated radiation therapy is generally safe and well-tolerated. A review of several studies found that this treatment often causes fewer side effects than traditional radiation. Specifically, one study found that more than half of the patients had no skin problems, and most experienced only mild side effects. Another study reported low rates of immediate harmful effects, known as acute toxicity. Overall, these findings suggest that hypofractionated radiation therapy is a safe option for many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about hypofractionated radiation therapy for breast cancer because it offers a more convenient and potentially equally effective option compared to traditional radiation therapy. Unlike standard radiation, which usually requires daily sessions over 5-6 weeks, hypofractionated radiation is delivered over a shorter period of 3-4 weeks. This condensed schedule can be more manageable for patients, reducing the time spent in treatment and potentially improving quality of life. Additionally, hypofractionated therapy may maintain similar effectiveness in targeting cancer cells, making it an attractive alternative to the lengthy standard approach.

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

Studies have shown that hypofractionated radiation therapy, which participants in this trial may receive, effectively treats breast cancer. Research indicates that it delivers higher doses of radiation in fewer sessions without compromising safety or effectiveness. One study found that 69.8% of women who received this treatment had good cosmetic results after 10 years, similar to those who underwent traditional treatment. Another study demonstrated that it works as well as the traditional method but requires less time. Overall, hypofractionated radiation therapy shows promise in preventing cancer recurrence with fewer side effects. ^{1 3 4 6 7}

Who Is on the Research Team?

Matthew Poppe, MD

Principal Investigator

Huntsman Cancer Hospital, University of Utah

Are You a Good Fit for This Trial?

This trial is for women with stage IIa-IIIa breast cancer who've had a mastectomy. They must not be pregnant, have no history of certain other cancers or severe diseases, and agree to birth control if of childbearing potential. Participants should not have received prior chest radiation and must plan to start treatment within specific timeframes.

Inclusion Criteria

I haven't had radiation therapy to my chest, neck, or armpit area; but I may have had radioactive iodine treatment.

My mastectomy showed no cancer cells at the edges of the removed tissue.

I have never had invasive breast cancer in my other breast.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks

5-6 weeks

Hypofractionated Radiation Therapy

Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests hypofractionated radiation therapy, which uses higher doses over a shorter period than traditional radiation, after mastectomy to prevent cancer recurrence. It includes lab biomarker analysis and quality-of-life assessments.

How Is the Trial Designed?

Group I: Group II (hypofractionated radiation therapy) Experimental Treatment 4 Interventions

Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.

Group II: Group I (radiation therapy) Active Control 4 Interventions

Patients undergo radiation therapy daily on Monday-Friday for 5-6 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?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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. 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.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)30932-6/fulltext

Hypofractionated breast radiotherapy for 1 week versus 3 ... FAST-Forward results confirm that 26 Gy in five fractions is as effective and safe as an international standard 15-fraction regimen after ...

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. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00144-6/abstract

First results of the UNICANCER HypoG-01 phase III trial Favorable safety profile of moderate hypofractionated over normofractionated radiotherapy in breast cancer patients: a multicentric prospective real-life data ...