Hypofractionated Radiation for Breast Cancer

Not currently recruiting at 4 trial locations

Overseen By Mary Martin, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Disqualifiers: T4 disease, Other malignancy, Radiation history, Collagen vascular disease, Pregnancy, 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: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new radiation treatment method for breast cancer called hypofractionated radiation. It targets patients who have undergone breast cancer surgery and require radiation to the breast and nearby lymph nodes. Participants will be divided into two groups based on their previous surgery details. This trial may suit women who have had breast cancer surgery, do not have other serious health conditions, and can attend follow-up visits over three years. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future breast cancer treatments.

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.

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

The trial protocol does not specify whether you need to stop taking your current medications.

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

Studies have shown that hypofractionated radiation, a shorter course of radiation treatment for breast cancer, is generally safe. Research indicates that most patients handle this treatment well. For example, one study found that more than half of the patients experienced no skin problems, a common concern with radiation therapy. Another study reported low rates of immediate side effects, indicating that patients did not face severe issues immediately after treatment. Additionally, long-term results demonstrated that most women had good or excellent cosmetic outcomes, with minimal changes to their appearance over time. Overall, the evidence suggests that hypofractionated radiation is a well-tolerated option for breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hypofractionated radiation for breast cancer because it offers a potentially quicker and more convenient treatment option compared to traditional radiation therapy. Standard radiation treatments typically require daily sessions over several weeks, while hypofractionated radiation delivers higher doses in fewer sessions, reducing the overall treatment time. Additionally, this approach may help minimize the exposure to healthy tissues and reduce side effects, making it a promising alternative for patients seeking effective yet less burdensome treatment options.

What evidence suggests that hypofractionated radiation might be an effective treatment for breast cancer?

Research has shown that hypofractionated radiation, a type of radiation treatment given in larger doses over a shorter time, works well for breast cancer. One study found that about 69.8% of women who received this treatment had good or excellent cosmetic results after 10 years. Another study demonstrated that hypofractionated radiation is as safe and effective as the traditional method, which requires more sessions. Additionally, this treatment is associated with low rates of harmful side effects that appear shortly after treatment. Overall, these studies suggest that hypofractionated radiation is a promising option for treating breast cancer.

In this trial, participants will be divided into two groups: Group 1 will undergo a sentinel lymph node procedure with or without select removal of clipped lymph nodes, while Group 2 will undergo axillary lymph node dissection. ^{1 3 4 6 7}

Who Is on the Research Team?

Joshua T. Dilworth

Principal Investigator

William Beaumont Hospitals

Are You a Good Fit for This Trial?

This trial is for women over 18 with breast cancer who have a life expectancy of more than 5 years and are in good physical condition. They must not be pregnant, breastfeeding, or refuse contraception if of child-bearing potential. Participants should have certain stages of tumor and node involvement but no history of radiation to the neck, breast, or thorax.

Inclusion Criteria

Life expectancy of >5 years

I am fully active and can carry on all my pre-disease activities without restriction.

My cancer has not spread to more than a few nearby lymph nodes.

Exclusion Criteria

My cancer has spread to nearby lymph nodes but not to distant parts of my body.

Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential

My scans show visible signs of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline consultations, history and physical, lymphedema assessment, toxicity assessment, photographs (optional), patient-reported outcome questionnaire and radiation simulation

1 week

1 visit (in-person)

Treatment

Hypofractionated radiation therapy completed weekly with toxicity assessments

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1-2 weeks, 3 months, 6 months, 1 year, 2 years, and 3 years

3 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation

Trial Overview The study tests hypofractionated regional nodal irradiation's effectiveness and safety in breast cancer patients post-surgery. It involves two groups based on axillary surgery extent, with follow-ups from 1-2 weeks up to 3 years after treatment completion.

How Is the Trial Designed?

Group I: Group 2: axillary lymph node dissection Experimental Treatment 1 Intervention

Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.

Group II: Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes Experimental Treatment 1 Intervention

Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.

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

Approved in United States as Hypofractionated Radiotherapy for:

• Endometrial cancer

Approved in European Union as Hypofractionated Radiotherapy for:

• Endometrial cancer
• Cervical cancer

Approved in Canada as Hypofractionated Radiotherapy for:

• Endometrial cancer

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Published Research Related to This Trial

In a study of 2309 breast cancer patients, those receiving hypofractionated radiotherapy experienced significantly less acute skin reactions and pain compared to those receiving conventional fractionation, indicating a safer treatment option.

Hypofractionation also resulted in lower levels of patient-reported symptoms like burning, swelling, and fatigue during treatment, suggesting it may enhance patient comfort without compromising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort. Jagsi, R., Griffith, KA., Boike, TP., 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]

Recent advancements in radiation therapy for non-metastatic breast cancer, particularly hypofractionation and partial breast irradiation, have led to optimized treatment approaches that consider both patient and tumor characteristics.

Despite strong level-1 evidence supporting hypofractionation, its adoption in routine practice has been slow, prompting the AIRO Breast Cancer Group to issue position statements aimed at standardizing postoperative radiation therapy practices based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Italian Association for Radiotherapy and Clinical Oncology (AIRO) position statements for postoperative breast cancer radiation therapy volume, dose, and fractionation. Meattini, I., Palumbo, I., Becherini, C., et al.[2023]

Hypofractionation for whole-breast irradiation is safe and effective, providing similar local control and cosmetic outcomes compared to traditional methods, as supported by recent randomized trials.

There is growing interest in using hypofractionation for partial-breast irradiation, with early studies showing promising local control and manageable side effects, while larger randomized trials are currently being conducted to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience using hypofractionated radiation schedules in breast cancer. Whelan, TJ., Kim, DH., Sussman, J.[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, 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]

In a study involving 92 patients undergoing post-mastectomy radiation therapy (PMRT) with a hypofractionated regimen of 43.5 Gy over 15 days, the majority experienced mild skin toxicities, with 62% developing grade 2 dermatitis, which mostly resolved within three months.

The hypofractionated approach demonstrated a low incidence of significant acute toxicities, while effectively covering the target areas, although it resulted in a slightly higher dose to the ipsilateral lung compared to the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in postmastectomy locally advanced breast cancer: an interim report on acute toxicities and dosimetry. Jamora, K., Cruz-Lim, EM., Cereno, RE., et al.[2023]

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]

Hypofractionated whole breast irradiation (WBI) has been shown to produce outcomes comparable to conventional radiation in early-stage breast cancer patients, suggesting it is a safe and effective treatment option.

Current trials, including a phase III study by the Radiation Therapy Oncology Group, are investigating the feasibility and effectiveness of adding a concurrent tumor bed boost to hypofractionated WBI, which may enhance treatment outcomes and broaden its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated fractionation with a concurrent boost for early stage breast cancer. Freedman, GM., White, JR., Arthur, DW., et al.[2022]

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]

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]

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/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 ...

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, including ...

4. 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 ...

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

First results of the UNICANCER HypoG-01 phase III trial Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy compared with a standard 3-week regimen delivered in the UK FAST-Forward ...