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

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

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.

Is hypofractionated radiation therapy safe for humans?

Research shows that hypofractionated radiation therapy (HFRT) is generally safe for treating early-stage breast cancer, with similar safety to traditional radiation therapy. Studies have looked at side effects and found that HFRT is well-tolerated, though some concerns about local control and toxicity remain. ^{1 2 3 4 5}

How is hypofractionated radiation therapy different from other treatments for early-stage breast cancer?

Hypofractionated radiation therapy (HFRT) is unique because it delivers higher doses of radiation in fewer sessions compared to conventional radiation therapy, making it more convenient for patients. It has been shown to be as effective and safe as traditional methods, with potential benefits like reduced treatment time and similar outcomes in terms of cancer control and side effects. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Hypofractionated Radiation Therapy for Early-Stage Breast Cancer?

Research shows that hypofractionated radiation therapy (HFRT) is as effective and safe as traditional radiation therapy for early breast cancer, with the added benefit of requiring fewer treatment sessions. Studies have found that HFRT has similar local recurrence rates and manageable side effects, making it a promising option for patients. ^{1 3 4 5 6}

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 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]

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 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 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]

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]

Citations

1. India 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? [2022]

2. United States 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. [2022]

3. India pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. [2018]

6. India pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]