Hypofractionated Radiation Therapy for Early-Stage Breast Cancer

(NOVEMBER Trial)

Overseen By Ashley Horstmeier

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Radiation sensitizers

Disqualifiers: Prior radiation, Collagen vascular diseases, 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: 11

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether hypofractionated radiation therapy effectively treats early-stage breast cancer. The treatment delivers higher radiation doses over a shorter period, potentially killing more tumor cells and causing fewer side effects. It targets women who have had a lumpectomy without cancer spread to lymph nodes or other body parts. Women with conditions such as lupus or scleroderma, or those who have had prior breast radiation, should not participate. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot take radiation sensitizing medications during the trial. It's best to discuss your current medications with the trial team.

What prior data suggests that hypofractionated radiation therapy is safe for early-stage breast cancer?

Research has shown that hypofractionated radiation therapy is generally safe for patients with early-stage breast cancer. Studies have found that patients tolerate this treatment well, with many experiencing only a few side effects. In one study, more than half of the patients did not experience skin problems, a common concern with radiation therapy. Additionally, long-term results indicate that this treatment usually preserves the breast's appearance, avoiding noticeable changes. Overall, the safety data suggests that this treatment option is effective and manageable for patients. ^{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 larger doses over a shorter period, specifically 9 fractions over 2 weeks, compared to the traditional schedule of 5 to 7 weeks. This condensed treatment schedule is not only more convenient for patients, reducing the number of hospital visits, but also has the potential to maintain or even improve effectiveness while minimizing side effects. Researchers are excited about this approach because it could significantly enhance the quality of life for patients by balancing treatment efficacy with a patient's time and comfort.

What evidence suggests that hypofractionated radiation therapy might be an effective treatment for early-stage breast cancer?

Research has shown that hypofractionated radiation therapy (HFRT), which participants in this trial will receive, works as well as conventional radiation therapy (CFRT) for early-stage breast cancer. Studies have found no difference between HFRT and CFRT in preventing cancer recurrence and extending patient survival. In simpler terms, both treatments are equally effective at stopping cancer from returning and prolonging life. Additionally, HFRT has maintained a good appearance of the treated area over time. Most patients experience positive outcomes with only minor side effects, such as mild skin irritation or fatigue. ^{2 3 6 7 8}

Who Is on the Research Team?

Matthew M. Poppe

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

This trial is for women with stage 0-IIB breast cancer who can consent to treatment, use birth control or abstain from sex during therapy, and have a good performance status. They must not have had prior chest radiation, other recent cancers (except certain skin cancers or cervical carcinoma in situ), severe medical conditions, or collagen vascular diseases.

Inclusion Criteria

I am a woman capable of becoming pregnant.

I agree to use birth control or abstain from sex during radiation therapy.

I am fully active or can carry out light work.

Exclusion Criteria

I have had breast cancer or DCIS on the same side before, but LCIS or benign conditions are okay.

I had complications after a lumpectomy that needed more surgery or IV antibiotics.

My other health conditions do not reduce my life expectancy to less than 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks

2 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

Visits at 2-8 weeks, 6 months, and annually for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy

Trial Overview The study tests hypofractionated radiation therapy on patients with early-stage breast cancer. This method uses higher doses over fewer sessions compared to traditional treatments and aims to be more effective with less side effects.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 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 Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

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]

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 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 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885449/

Hypofractionated Radiotherapy for Early-Stage Breast ... The hypothesis is that hypofractionated RT for early stage breast cancer is as effective as conventional RT for local tumor control. The co-primary endpoints of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24750510/

Hypofractionated radiation therapy for early stage breast ... Toxicities were limited to grade 1 dermatitis in 32 patients (38%) and grade 2 fatigue in three (4%). Sixty-three patients (75%) reported good or excellent ...

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. 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 ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.753209/full

A Meta-Analysis of Randomized Controlled Trials Conclusion: Our results suggest that there is no statistical difference between HFRT and CFRT in terms of LR, RFS, OS, and cosmetic outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6457862/

Hypofractionated radiation therapy for early breast cancer - PMC Breast cancer‐specific survival (HR 0.91, 95% CI 0.78 to 1.06, 5685 women, three studies, high quality evidence) and relapse‐free survival (HR 0.93, 95% CI 0.82 ...

7. 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 ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-11918-2

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