Radiation Therapy for Breast Cancer

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Severe illnesses, Active infection, Pregnancy, 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: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to radiation therapy for breast cancer, using hypofractionated radiation therapy. This method delivers higher doses of radiation over a shorter period. The goal is to determine if it can kill more tumor cells with fewer side effects before surgery. Individuals with early-stage breast cancer planning to undergo breast surgery and eligible for radiation may be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the 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.

What prior data suggests that hypofractionated radiation therapy is safe for breast cancer treatment?

Research has shown that hypofractionated radiation therapy is generally well-tolerated by breast cancer patients. This method uses higher doses of radiation over a shorter period and often results in fewer skin issues. For instance, one study found that more than half of the patients experienced no skin problems. Another study reported that few patients encountered significant side effects during treatment.

Furthermore, hypofractionated radiation therapy has demonstrated a strong safety record, with no severe side effects reported. Both during and after treatment, patients experienced minimal negative effects. Overall, the treatment appears safe and manageable for recipients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hypofractionated radiation therapy is unique because it delivers radiation in higher doses over a shorter period, specifically just five days, compared to the conventional weeks-long radiation schedule. This approach is not only more convenient for patients but also has the potential to reduce the overall treatment time without compromising effectiveness. Researchers are excited about this treatment because it could lead to faster recovery times and less disruption to patients' lives while maintaining similar outcomes to the standard of care.

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

Studies have shown that hypofractionated radiation therapy, which participants in this trial will undergo, effectively treats breast cancer. Research indicates it can be as effective and safe as traditional methods. One study found low rates of side effects and good cosmetic results. Another study confirmed that shorter treatment schedules are as effective as longer ones. This therapy delivers higher doses over fewer sessions, potentially killing more cancer cells while reducing side effects. ^{1 3 4 6 7}

Who Is on the Research Team?

Carlos E. Vargas, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with confirmed breast cancer, clinical stage T0-T2 N0 M0, who can consent and complete tests. They must be able to visit the institution for follow-up and are planning surgery with whole breast radiotherapy. It's not for pregnant women, those not using contraception, prior chest radiation patients, recurrent cancer cases or people with severe illnesses.

Inclusion Criteria

Able to and provides Institutional Review Board (IRB) approved study specific written informed consent

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Study entry must be within 120 days of last biopsy (breast)

Exclusion Criteria

My treatment plan includes radiation therapy for lymph nodes.

I have not received any initial treatment before the main therapy.

I cannot undergo radiotherapy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo hypofractionated radiation therapy daily for 5 days

1 week

5 visits (in-person)

Surgery

Participants undergo standard of care surgery 4-16 weeks after radiation therapy

4-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 12 weeks, 6, 12, 24, and 36 months, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study is examining hypofractionated radiation therapy before surgery in breast cancer patients. This method involves higher doses of radiation over a shorter period than traditional treatments, potentially improving tumor control with fewer side effects.

How Is the Trial Designed?

Group I: Treatment (hypofractionated radiation therapy) Experimental Treatment 1 Intervention

Participants undergo hypofractionated radiation therapy daily for 5 days, then undergo standard of care surgery 4-16 weeks after radiation therapy.

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 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 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 3518 breast cancer patients, moderately hypofractionated whole-breast radiotherapy (HFRT) resulted in significantly lower rates of acute dermatitis, breast edema, and hyperpigmentation compared to normofractionated radiotherapy (NFRT), indicating HFRT's safety and efficacy in real-life settings.

HFRT also led to less pain in patients (33.4% vs. 53.7% with NFRT), suggesting it may be a preferable treatment option, especially for patients with higher BMI or larger breast sizes, despite these factors being associated with increased dermatitis risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Favorable safety profile of moderate hypofractionated over normofractionated radiotherapy in breast cancer patients: a multicentric prospective real-life data farming analysis. Issoufaly, I., Petit, C., Guihard, S., 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 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]

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. 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.