Shorter Course Radiation for Breast Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Male, T4 disease, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

108 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the treatment Adjuvant Hypofractionated Radiation for breast cancer?

Research shows that shorter courses of hypofractionated radiation therapy are as effective as longer, conventional courses for treating breast cancer, with similar survival rates and reduced risk of cancer returning. This approach is also more convenient and less costly for patients. ^{1 2 3 4 5}

Is shorter course radiation therapy for breast cancer safe?

Research shows that shorter courses of radiation therapy, known as hypofractionated radiation, are generally safe for breast cancer patients. Studies have found no significant increase in harmful side effects compared to traditional longer courses, although some side effects may take years to appear. ^{2 3 6 7 8}

How is the treatment Adjuvant Hypofractionated Radiation different from other treatments for breast cancer?

Adjuvant Hypofractionated Radiation is unique because it uses fewer, larger doses of radiation over a shorter period, typically one to three weeks, compared to the traditional five-week schedule. This approach is more convenient, less costly, and has been shown to provide similar outcomes in terms of cancer control and survival for many patients with early-stage breast cancer. ^{2 3 4 9 10}

What is the purpose of this trial?

This trial is testing a new, quicker way to give radiation therapy to breast cancer patients who have had surgery and have cancer cells in their lymph nodes. The treatment aims to deliver the same total amount of radiation in less time, which has been shown to be safe and effective for breast tissue but needs more testing for larger areas. Recent trials have shown that these methods are safe and effective for breast tissue.

Research Team

Christine Fisher, MD, MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adult women with breast cancer who've had surgery and found cancer in their lymph nodes. They must be under 50, may have had chemo, and should not have severe side effects from past treatments. Their last surgery or chemo should be within the past 180 days, they need to understand and agree to the study by signing a consent form.

Inclusion Criteria

Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient

Subjects will have the ability to understand, and the willingness to sign a written informed consent document

I am a woman under 50, had chemotherapy, have a specific cancer stage, or am large-breasted.

Exclusion Criteria

Pregnant women

It's been over 6 months since my breast surgery or chemotherapy.

I have had radiation therapy on the same side of my chest or breast before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a shortened course of radiation treatment lasting approximately 3-4 weeks, with 15 treatments and an optional 4 additional fractions as a boost.

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for disease recurrence, metastasis-free survival, and adverse events.

60 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as lymphedema, quality of life changes, and other adverse events.

60 months

Treatment Details

Interventions

• Adjuvant Hypofractionated Radiation

Trial Overview The study tests a shorter radiation treatment schedule for breast cancer that has spread to lymph nodes after surgery. It aims to see if this quicker method is as effective as traditional longer courses of radiation therapy.

Participant Groups

Group I: Adjuvant Hypofractionated Radiation Experimental Treatment 1 Intervention

Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

A study of 380 breast cancer patients treated with a short hypofractionated radiotherapy schedule showed very low local relapse rates, with only 0.2% at 2 years and 2% at 5 years, indicating high efficacy.

The treatment also resulted in excellent overall survival rates of 97.4% at 2 years and 95% at 5 years, suggesting that this short radiotherapy schedule is a safe and effective alternative to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten Daily Fractions for Whole Breast Cancer Irradiation: Long Term Results. Belgioia, L., Fozza, A., Trapani, L., et al.[2021]

The use of hypofractionated radiation therapy (RT) for breast cancer treatment increased from 3.8% in 2006 to 13.6% by 2009-2010 among low-risk older patients, indicating a growing acceptance of this more convenient and cost-effective treatment option.

Despite the increase in hypofractionation use, it remained low overall, especially among patients over 80 years old, while the adoption of intensity-modulated RT (IMRT) rose significantly during the same period, highlighting a disparity in the uptake of these two treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Jagsi, R., Falchook, AD., Hendrix, LH., et al.[2022]

Radiation therapy (RT) as part of breast-conserving treatment or post-mastectomy significantly reduces the risk of local-regional recurrence and improves long-term survival, with most studies using daily doses of 1.8-2 Gray (Gy).

Recent studies on hypofractionated RT schedules, which deliver equivalent doses in a shorter time, have shown similar effectiveness in preventing recurrence and survival rates, with no significant increase in acute or long-term toxicities, although further research is needed to identify suitable patient groups for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated course of radiotherapy (RT) for breast cancer. Schoenfeld, JD., Harris, JR.[2018]

Hypofractionation in radiotherapy for breast cancer has a strong empirical foundation, showing that shorter treatment schedules can be effective.

Clinical trials have successfully established new standards of care, reducing treatment from 50 Gy in 25 fractions over 5 weeks to as low as 26 Gy in 5 fractions over just 1 week, making treatment more efficient for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From 25 Fractions to Five: How Hypofractionation has Revolutionised Adjuvant Breast Radiotherapy. Yarnold, JR., Brunt, AM., Chatterjee, S., et al.[2022]

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]

The UK-FAST trial showed that a once weekly hypofractionated radiotherapy regimen (5 fractions of 5.7 Gy) for whole breast irradiation had similar toxicity levels compared to the conventional regimen (50 Gy in 25 fractions) over a 10-year follow-up, indicating it is a safe alternative.

The FAST-Forward trial demonstrated that a 5-fraction regimen (5.2 Gy per fraction) over one week is non-inferior in local control compared to the standard 40 Gy in 15 fractions over three weeks, supporting the efficacy of extreme hypofractionation in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. Bockel, S., Louvel, G., Brion, T., et al.[2021]

Randomized trials indicate that hypofractionation using 2.67 Gy fractions for adjuvant whole breast radiotherapy does not compromise local tumor control or increase late adverse effects, suggesting it is a safe treatment option.

There is potential for even fewer larger fractions to be safely administered, but ongoing research is needed to determine the effectiveness and safety of a 5-fraction schedule, especially considering the volume of breast tissue treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy. Yarnold, J., Haviland, J.[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]

A multicenter randomized controlled trial in India is testing whether a 1-week (5 fractions) regimen of hypofractionated radiotherapy is non-inferior to the standard 3-week (15 fractions) schedule for breast cancer patients, with a target sample size of 2100 participants.

If successful, the 1-week regimen could improve access to radiotherapy and reduce treatment costs, while also ensuring safety and efficacy in patients with advanced disease requiring regional nodal radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)-study protocol for a multicentre, randomized phase III trial. Chatterjee, S., Chakraborty, S.[2021]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Ten Daily Fractions for Whole Breast Cancer Irradiation: Long Term Results. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Abbreviated course of radiotherapy (RT) for breast cancer. [2018]

4. England pubmed.ncbi.nlm.nih.gov

From 25 Fractions to Five: How Hypofractionation has Revolutionised Adjuvant Breast Radiotherapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Changes in radiotherapy fractionation-breast cancer. [2022]

6. United States 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. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Extreme hypofractionation: New indications for breast cancer radiotherapy]. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Pushing the limits of hypofractionation for adjuvant whole breast radiotherapy. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)-study protocol for a multicentre, randomized phase III trial. [2021]